Friday, March 31, 2006
FDA Warning about laser hair removal devices and equipment
The popularity of laser hair removal has increasingly grown, prompting many laser manufacturers to conduct research and seek FDA clearance for their lasers for this indication.
The market is growing so quickly that FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal, as this list continues to change.
To learn if a specific manufacturer has received FDA clearance, you can check FDA’s Website at http://www.fda.gov/cdrh/databases.html under the 510(k) database. Y
ou will need to know the manufacturer or device name of the laser. You can also call FDA’s Center for Devices and Radiological Health, Consumer Staff, at 1-888-INFO-FDA or 301-827-3990, fax your request to 301-443-9535 or send an e-mail to: DSMICA@cdrh.fda.gov.
Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure.
Further, manufacturers may not claim that laser hair removal is either painless or permanent unless the FDA determines that there are sufficient data to demonstrate such results.
Several manufacturers received FDA permission to claim, “permanent reduction,” NOT “permanent removal” for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair.
The specific claim granted is “intended to effect stable, long-term, or permanent reduction” through selective targeting of melanin in hair follicles.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions. The number of hairs regrowing must be stable over time greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location.
Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area.
FDA does not make comparisons between systems or how well or safely they work compared to another company’s system. FDA does not recommend one laser system over another.
Lasers cleared for body hair removal are also cleared for facial hair removal.
The market is growing so quickly that FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal, as this list continues to change.
To learn if a specific manufacturer has received FDA clearance, you can check FDA’s Website at http://www.fda.gov/cdrh/databases.html under the 510(k) database. Y
ou will need to know the manufacturer or device name of the laser. You can also call FDA’s Center for Devices and Radiological Health, Consumer Staff, at 1-888-INFO-FDA or 301-827-3990, fax your request to 301-443-9535 or send an e-mail to: DSMICA@cdrh.fda.gov.
Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure.
Further, manufacturers may not claim that laser hair removal is either painless or permanent unless the FDA determines that there are sufficient data to demonstrate such results.
Several manufacturers received FDA permission to claim, “permanent reduction,” NOT “permanent removal” for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair.
The specific claim granted is “intended to effect stable, long-term, or permanent reduction” through selective targeting of melanin in hair follicles.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions. The number of hairs regrowing must be stable over time greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location.
Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area.
FDA does not make comparisons between systems or how well or safely they work compared to another company’s system. FDA does not recommend one laser system over another.
Lasers cleared for body hair removal are also cleared for facial hair removal.
Wednesday, March 29, 2006
Laser Hair Removal - Finding The Best Laser For Safe, Effective, Affordable Hair Removal -- Part I
Laser Hair Removal - Finding The Best Laser For Safe, Effective, Affordable Hair Removal -- Part I
Laser Hair Removal. Finding The Best Laser For Safe, Effective, Affordable Hair Removal. Medical Spa and Laser Hair Removal Expert in Raleigh, NC Provides Guidelines.
June 22, 2005 (LHRI) -- Laser Hair Removal: A Guide to finding effective, safe fast and affordable laser hair removal treatments. Raleigh Laser Hair Removal and medical spa expert Kile Law Provides guidelines for choosing the appropriate Laser Hair Removal system.
Laser hair removal has come a long way since the first laser for hair removal received FDA clearance in the mid 1990’s. Older generation lasers were very slow, very painful and worked only on individuals with very dark hair and very light skin. Today, lasers can work on all skin colors and some lasers are even safe for treating tanned skinned.
Which laser to choose? - Spot size
The spot size of a laser determines how much skin area can be covered per laser pulse. Lasers with larger spot sizes (18 mm)can cover more area much more quickly. For example, a laser hair removal treatment of the back or full legs could take as long as 2 hours with older lasers. Today, these areas can be completely treated in less than 20 minutes.
The spot size not only determines the speed and comfort of the treatment, but the efficacy as well. In the April 2004 issue of Derm Surgery, a peer reviewed medical study showed that lasers with an 18 mm spot size (exclusive to the Candela GentleLase www.candelallaser.com ) was more effective at removing hair than lasers with smaller spot sizes.
-Cooling systems
Each laser has a different way of cooling the skin. Some lasers use a topical cooling gel, others use a chilled tip. The most consistent, comfortable and safest way to cool the skin is with a Dynamic Cooling Device or DCD. Lasers equipped with a DCD cooling system are so effective in providing cooling to the skin that no topical numbing creams are necessary.
-Light Sources
Intense Pulsed Light (IPL) Systems are not lasers. They can remove hair, but recent peer reviewed medical studies show that most lasers are much more effective in treating unwanted hair than IPL systems
Choosing a Laser Hair Removal Center
Board Certified Physician
Many laser hair removal centers today operate without a physician. It is important to be certain that a board certified physician is on the premises or available in case of a concern. To determine whether or not a physician is board certified, go to www.abms.org. Board certified plastic surgeons can be found at www.plasticsurgery.org
Possible complications:
Complications with newer laser hair removal systems (built in 2002 or later) is not common, particularly if the laser is equipped with a Dynamic Cooling Device. It is important, however to determine how the laser clinic handles potential complications. Is there a physician available to examine the problem and prescribe medications if necessary?
(continued)
Blue Water Spa is a plastic Surgery Medical Spa owned and operated by board-certified plastic surgeon Dr. Michael Law. Blue Water Medical Spa offers laser hair removal, facials, microdermabrasion, chemical peels, massage, Botox, Restylane and the full spectrum of aesthetic surgery procedures performed by nationally known board-certified plastic surgeon Dr. Michael Law. Dr. Law has returned to his hometown of Raleigh North Carolina to raise his family after practicing aesthetic surgery in Beverly Hills. Dr. Law has been featured in many national magazines and interviewed for news programs, but he has declined invitations to participate in plastic surgery reality television programs. Blue Water Medical Spa and Dr. Law have received many "best of" awards in their area since opening their business in 2003.
Kile Law, president of Blue Water Spa was recently appointed to the 2005 board of directors for the National Day Spa Association www.dayspaaassocation.com. She is one of ten individuals nationwide chosen for this prestigious position. Kile is often a featured speaker at medical spa and skin care conferences. She is the winner of the 2004 ABBIES award www.abbies.org/2004winners.html for writing, one of the aesthetic industry's highest honors for a series of articles she wrote in Skin Inc. Magazine, www.skininc.com entitled "Starting from Scratch" Her articles documented the amazing success of Blue Water Medical Spa since opening. Blue Water Spa has been featured in cover articles of many national magazines http://www.bluewaterspa.com/media.html and spa publications such as the Medical Spa Report www.medicalspareport.com. An interview with Kile as part of a panel of recognized experts in medical spas and laser hair removal appeared in the November / December 2004 Issue Of Luxury Spa Finder Magazine. Luxury Spa Finder is the largest consumer spa magazine in the country.
For more information, go to www.bluewaterspa.com or www.michaellawmd.com.
Laser Hair Removal. Finding The Best Laser For Safe, Effective, Affordable Hair Removal. Medical Spa and Laser Hair Removal Expert in Raleigh, NC Provides Guidelines.
June 22, 2005 (LHRI) -- Laser Hair Removal: A Guide to finding effective, safe fast and affordable laser hair removal treatments. Raleigh Laser Hair Removal and medical spa expert Kile Law Provides guidelines for choosing the appropriate Laser Hair Removal system.
Laser hair removal has come a long way since the first laser for hair removal received FDA clearance in the mid 1990’s. Older generation lasers were very slow, very painful and worked only on individuals with very dark hair and very light skin. Today, lasers can work on all skin colors and some lasers are even safe for treating tanned skinned.
Which laser to choose? - Spot size
The spot size of a laser determines how much skin area can be covered per laser pulse. Lasers with larger spot sizes (18 mm)can cover more area much more quickly. For example, a laser hair removal treatment of the back or full legs could take as long as 2 hours with older lasers. Today, these areas can be completely treated in less than 20 minutes.
The spot size not only determines the speed and comfort of the treatment, but the efficacy as well. In the April 2004 issue of Derm Surgery, a peer reviewed medical study showed that lasers with an 18 mm spot size (exclusive to the Candela GentleLase www.candelallaser.com ) was more effective at removing hair than lasers with smaller spot sizes.
-Cooling systems
Each laser has a different way of cooling the skin. Some lasers use a topical cooling gel, others use a chilled tip. The most consistent, comfortable and safest way to cool the skin is with a Dynamic Cooling Device or DCD. Lasers equipped with a DCD cooling system are so effective in providing cooling to the skin that no topical numbing creams are necessary.
-Light Sources
Intense Pulsed Light (IPL) Systems are not lasers. They can remove hair, but recent peer reviewed medical studies show that most lasers are much more effective in treating unwanted hair than IPL systems
Choosing a Laser Hair Removal Center
Board Certified Physician
Many laser hair removal centers today operate without a physician. It is important to be certain that a board certified physician is on the premises or available in case of a concern. To determine whether or not a physician is board certified, go to www.abms.org. Board certified plastic surgeons can be found at www.plasticsurgery.org
Possible complications:
Complications with newer laser hair removal systems (built in 2002 or later) is not common, particularly if the laser is equipped with a Dynamic Cooling Device. It is important, however to determine how the laser clinic handles potential complications. Is there a physician available to examine the problem and prescribe medications if necessary?
(continued)
Blue Water Spa is a plastic Surgery Medical Spa owned and operated by board-certified plastic surgeon Dr. Michael Law. Blue Water Medical Spa offers laser hair removal, facials, microdermabrasion, chemical peels, massage, Botox, Restylane and the full spectrum of aesthetic surgery procedures performed by nationally known board-certified plastic surgeon Dr. Michael Law. Dr. Law has returned to his hometown of Raleigh North Carolina to raise his family after practicing aesthetic surgery in Beverly Hills. Dr. Law has been featured in many national magazines and interviewed for news programs, but he has declined invitations to participate in plastic surgery reality television programs. Blue Water Medical Spa and Dr. Law have received many "best of" awards in their area since opening their business in 2003.
Kile Law, president of Blue Water Spa was recently appointed to the 2005 board of directors for the National Day Spa Association www.dayspaaassocation.com. She is one of ten individuals nationwide chosen for this prestigious position. Kile is often a featured speaker at medical spa and skin care conferences. She is the winner of the 2004 ABBIES award www.abbies.org/2004winners.html for writing, one of the aesthetic industry's highest honors for a series of articles she wrote in Skin Inc. Magazine, www.skininc.com entitled "Starting from Scratch" Her articles documented the amazing success of Blue Water Medical Spa since opening. Blue Water Spa has been featured in cover articles of many national magazines http://www.bluewaterspa.com/media.html and spa publications such as the Medical Spa Report www.medicalspareport.com. An interview with Kile as part of a panel of recognized experts in medical spas and laser hair removal appeared in the November / December 2004 Issue Of Luxury Spa Finder Magazine. Luxury Spa Finder is the largest consumer spa magazine in the country.
For more information, go to www.bluewaterspa.com or www.michaellawmd.com.
Laser Hair Removal - Finding The Best Laser For Safe, Effective, Affordable Hair Removal -- Part II
Laser Hair Removal - Finding The Best Laser For Safe, Effective, Affordable Hair Removal -- Part II
Laser Hair Removal. Finding The Best Laser For Safe, Effective, Affordable Hair Removal. Medical Spa and Laser Hair Removal Expert in Raleigh, NC Provides Guidelines.
June 22, 2005 (LHRI) -- Laser Hair Removal: A Guide to finding effective, safe fast and affordable laser hair removal treatments. Raleigh Laser Hair Removal and medical spa expert Kile Law Provides guidelines for choosing the appropriate Laser Hair Removal system.
Packages of treatments:
Laser Hair Removal works on hair while it is in the growth phase only. At any given time, between 20% to 40% of the hair on any face or body area may be in a growth phase. Multiple treatments are required for complete clearance of the hair. However, each person may respond slightly differently. Laser hair removal centers should charge for just one treatment at a time. A reputable medical office or medical spa offering laser hair removal will offer individual treatments and not insist on payment of multiple treatments up front.
Pricing:
Because lasers for hair removal are much faster today than ever before, prices should be lower as well. An office offering laser hair removal can charge less for a laser hair removal treatment of the legs taking just 20 minutes vs. a 2 hour treatment with an older generation laser. Avoid centers offering "specials" on treatment packages, particularly if there is pressure to buy because a "special" is set to expire.
Consultation:
A complimentary consultation should be available for you to visit the facility, meet the laser technician and experience a spot test with the laser.When considering a hair removal laser treatment, consumers should ask the following questions:
1) Is this laser FDA approved for hair removal on my skin type and hair color?
2) What is the spot size of the laser? In order for a laser to perform quickly and most effectively, it should have an 18mm spot size
3) Is the laser equipped with a dynamic cooling device (DCD)? This is the safest and most consistent method of cooling the skin. It ensures patient safety and comfort.
4) Is there a board-certified physician on site? A facility without appropriate medical supervision may not be the safest environment for a laser procedure.
5) Are treatments sold in a package or one at a time? Businesses that want your money up front may not have the confidence that their laser will perform effectively. A client should be able to pay for treatments as needed without paying all at once.
6) Are complimentary consultations and spot tests available? You should be able to meet the technician and experience a pulse or two before committing to a treatment.
Blue Water Spa is a plastic Surgery Medical Spa owned and operated by board-certified plastic surgeon Dr. Michael Law. Blue Water Medical Spa offers laser hair removal, facials, microdermabrasion, chemical peels, massage, Botox, Restylane and the full spectrum of aesthetic surgery procedures performed by nationally known board-certified plastic surgeon Dr. Michael Law. Dr. Law has returned to his hometown of Raleigh North Carolina to raise his family after practicing aesthetic surgery in Beverly Hills. Dr. Law has been featured in many national magazines and interviewed for news programs, but he has declined invitations to participate in plastic surgery reality television programs. Blue Water Medical Spa and Dr. Law have received many "best of" awards in their area since opening their business in 2003.
Kile Law, president of Blue Water Spa was recently appointed to the 2005 board of directors for the National Day Spa Association www.dayspaaassocation.com. She is one of ten individuals nationwide chosen for this prestigious position. Kile is often a featured speaker at medical spa and skin care conferences. She is the winner of the 2004 ABBIES award www.abbies.org/2004winners.html for writing, one of the aesthetic industry's highest honors for a series of articles she wrote in Skin Inc. Magazine, www.skininc.com entitled "Starting from Scratch" Her articles documented the amazing success of Blue Water Medical Spa since opening. Blue Water Spa has been featured in cover articles of many national magazines http://www.bluewaterspa.com/media.html and spa publications such as the Medical Spa Report www.medicalspareport.com. An interview with Kile as part of a panel of recognized experts in medical spas and laser hair removal appeared in the November / December 2004 Issue Of Luxury Spa Finder Magazine. Luxury Spa Finder is the largest consumer spa magazine in the country. For more information, go to www.bluewaterspa.com or www.michaellawmd.com
Laser Hair Removal. Finding The Best Laser For Safe, Effective, Affordable Hair Removal. Medical Spa and Laser Hair Removal Expert in Raleigh, NC Provides Guidelines.
June 22, 2005 (LHRI) -- Laser Hair Removal: A Guide to finding effective, safe fast and affordable laser hair removal treatments. Raleigh Laser Hair Removal and medical spa expert Kile Law Provides guidelines for choosing the appropriate Laser Hair Removal system.
Packages of treatments:
Laser Hair Removal works on hair while it is in the growth phase only. At any given time, between 20% to 40% of the hair on any face or body area may be in a growth phase. Multiple treatments are required for complete clearance of the hair. However, each person may respond slightly differently. Laser hair removal centers should charge for just one treatment at a time. A reputable medical office or medical spa offering laser hair removal will offer individual treatments and not insist on payment of multiple treatments up front.
Pricing:
Because lasers for hair removal are much faster today than ever before, prices should be lower as well. An office offering laser hair removal can charge less for a laser hair removal treatment of the legs taking just 20 minutes vs. a 2 hour treatment with an older generation laser. Avoid centers offering "specials" on treatment packages, particularly if there is pressure to buy because a "special" is set to expire.
Consultation:
A complimentary consultation should be available for you to visit the facility, meet the laser technician and experience a spot test with the laser.When considering a hair removal laser treatment, consumers should ask the following questions:
1) Is this laser FDA approved for hair removal on my skin type and hair color?
2) What is the spot size of the laser? In order for a laser to perform quickly and most effectively, it should have an 18mm spot size
3) Is the laser equipped with a dynamic cooling device (DCD)? This is the safest and most consistent method of cooling the skin. It ensures patient safety and comfort.
4) Is there a board-certified physician on site? A facility without appropriate medical supervision may not be the safest environment for a laser procedure.
5) Are treatments sold in a package or one at a time? Businesses that want your money up front may not have the confidence that their laser will perform effectively. A client should be able to pay for treatments as needed without paying all at once.
6) Are complimentary consultations and spot tests available? You should be able to meet the technician and experience a pulse or two before committing to a treatment.
Blue Water Spa is a plastic Surgery Medical Spa owned and operated by board-certified plastic surgeon Dr. Michael Law. Blue Water Medical Spa offers laser hair removal, facials, microdermabrasion, chemical peels, massage, Botox, Restylane and the full spectrum of aesthetic surgery procedures performed by nationally known board-certified plastic surgeon Dr. Michael Law. Dr. Law has returned to his hometown of Raleigh North Carolina to raise his family after practicing aesthetic surgery in Beverly Hills. Dr. Law has been featured in many national magazines and interviewed for news programs, but he has declined invitations to participate in plastic surgery reality television programs. Blue Water Medical Spa and Dr. Law have received many "best of" awards in their area since opening their business in 2003.
Kile Law, president of Blue Water Spa was recently appointed to the 2005 board of directors for the National Day Spa Association www.dayspaaassocation.com. She is one of ten individuals nationwide chosen for this prestigious position. Kile is often a featured speaker at medical spa and skin care conferences. She is the winner of the 2004 ABBIES award www.abbies.org/2004winners.html for writing, one of the aesthetic industry's highest honors for a series of articles she wrote in Skin Inc. Magazine, www.skininc.com entitled "Starting from Scratch" Her articles documented the amazing success of Blue Water Medical Spa since opening. Blue Water Spa has been featured in cover articles of many national magazines http://www.bluewaterspa.com/media.html and spa publications such as the Medical Spa Report www.medicalspareport.com. An interview with Kile as part of a panel of recognized experts in medical spas and laser hair removal appeared in the November / December 2004 Issue Of Luxury Spa Finder Magazine. Luxury Spa Finder is the largest consumer spa magazine in the country. For more information, go to www.bluewaterspa.com or www.michaellawmd.com
Didn't find what you were looking for?
Try searching Google for these keywords:
laser hair removal information, laser hair removal treatments for women and men
permanent laser hair removal, laser hair removal prices, laser hair removal cost, laser hair removal side effects,
laser facial hair removal, laser bikini hair removal, laser body hair removal,
laser pubic hair removal, laser hair removal pregnancy risk, epila laser hair removal
