Smart Practice
Know The Regulations Governing Esthetic Devices
By Kevin D. Heupel
Originally published in ASCP's Skin Deep, August/September 2007. Copyright 2007. Associated Skin Care Professionals. All rights reserved.
Esthetic devices are becoming more popular in salons, medi-spas, and medical clinics. The use of microdermabrasion, light-emitting diodes (LED), intense pulsed light (IPL), and laser therapies is growing. Though many medical devices are marketed for esthetic purposes, it is important to understand the regulation of esthetic devices, especially as it governs who can legally use them.
The Role of the FDA
What many people do not realize is that esthetic devices are regulated by the U.S. Food and Drug Administration (FDA). The FDA defines a medical device as "an instrument, apparatus, implement, or machine intended to affect the structure or any function of the body of man or other animal ..."i Given that esthetic devices are intended to affect the structure or function of the human body, the FDA requires registration of electrolysis, galvanic, microdermabrasion, IPL, and laser esthetic devices.
The FDA uses three classifications for medical devices:
Class I--Simple design and minimum potential for harm to user.
Class II--General controls alone are insufficient to assure safety and effectiveness, but existing methods are available to provide such assurances.
Class III--Devices where insufficient information exists to assure safety and effectiveness solely through controls.
Classification of Esthetic Devices
Some examples of class I medical items registered with the FDA are electrolysis, microdermabrasion, and galvanic devices. Class II examples include ultrasound, IPL, and laser devices.
One device that causes some confusion as to its classification is the LED. LED can be either a class I or II device depending on whether machines use red or blue light, implement ultraviolet or infrared radiation, what the range of the device's wavelengths are, and the device's intended use. Given the variations in LED devices, it's important to verify their classification with the FDA.
General Controls for Devices
The FDA requires general controls for class I, II, and III devices. The following general controls apply to all classes:ii
- 510(k) exempt.
- Establishment registration.
- Good manufacturing practices.
- Medical device listing.
- Proper labeling.
Good manufacturing practices ensure esthetic manufacturers are using machine parts and manufacturing practices that make safe machines. The establishment registration with the FDA refers to a requirement that organizations involved in the production and distribution of medical devices meant to be marketed or leased in the United States provide the FDA with the location of medical-device manufacturing facilities and importers.iii This includes manufacturers, initial importers, foreign establishments, and distributors. Unfortunately, it is not uncommon for devices to be imported illegally or manufactured illegally in the United States and sold to the beauty industry.
Using the Establishment Registration
The establishment registration provides a way for estheticians and physicians to ensure a machine is lawful and safe. Before you buy any esthetic device, make sure you obtain and verify the establishment registration. The seller can provide this number, and you can verify the registration on the FDA website: www.fda.gov/cdrh.
Manufacturers sell products under different names or register new products under a group of existing products. The surest way to verify registration is to have the seller provide the establishment number and then enter that registration on the FDA website. Otherwise, results are only as good as your search, which can be inconclusive at best.
Special Controls for Class II Devices
In addition to general controls applicable to all machines, class II and III devices require a 510(k) filing on premarket notification of intended use, mandatory performance standards, and post-market surveillance.iv Intended use is an important concept since it requires sale of the devices to physicians or other licensed professionals as prescriptive devices.v This is where estheticians can get in trouble with state cosmetology and medical boards. Who determines which licensed practitioners can use class II devices? Some think it should fall on the FDA, but the FDA relies on individual states to make this determination. Thus, it is up to state cosmetology and medical boards to decide whether class II devices can be independently operated by licensed estheticians or cosmetologists.
State Regulation of Esthetic Devices
FDA classification and registration requirements are complex and have made it difficult for cosmetology and medical boards to regulate use of such devices. States have tried a variety of approaches to provide some clear guidance to estheticians and physicians. In Colorado and Washington, for example, cosmetology rules--in conjunction with medical board regulations pertaining to supervision and delegation--permit licensed estheticians and cosmetologists to use any class I device. Estheticians and cosmetologists can use class II devices, such as lasers, but only under a licensed physician's delegation. All devices, regardless of classification, must be properly registered with the FDA. The use of unregistered devices is a violation in itself.
State Approaches Differ
An esthetician in Colorado or Washington who uses a class II device without medical delegation risks being disciplined by the cosmetology board, sued by the medical board for practicing medicine without a license, and criminally charged for impersonating a physician.
Oregon and Iowa have similar policies, but with some looser restrictions for class II devices. Licensed estheticians and cosmetologists in Oregon can use any class I and II devices. However, estheticians can only use class II devices within their intended use related to the practice of esthetics. This is where the 510(k) filing becomes important, as it details the intended use. So long as estheticians are using the class II devices within their intended use, the operation of the device is legal. This includes the use of lasers and IPL by estheticians. If estheticians use the devices beyond their intended scope, it constitutes the unlicensed practice of medicine and is subject to a variety of penalties.
California takes a different approach. Physicians may use such class II devices as lasers or IPL devices. Physician assistants and registered nurses may perform these treatments under a physician's supervision. Unlicensed medical assistants, cosmetologists, electrologists, and estheticians may not legally perform these treatments under any circumstances, nor may registered nurses or physician assistants perform them without supervision.
Do Your Homework
States take a variety of approaches to the regulation and use of esthetic devices. Before purchasing an expensive machine, it is important to make sure using the device is within your scope of practice. Contact your state medical and cosmetology boards. Once you determine that use of the machine is permissible, make sure the machine is lawfully registered with the FDA. Taking these steps will keep you within your legal scope of practice and promote safe esthetic practices. Otherwise, you are risking your client's safety and your livelihood.
* * *
Kevin D. Heupel is a licensed attorney specializing in beauty and salon legal issues and is the former director of the Colorado Office of Cosmetology. For more information: www.heupellaw.com or www.scec.biz.
Notes
i U.S. Federal Food, Drug, and Cosmetic Act sec. 201(h)
iiTitle 21, U.S. Congress, sec. 360c, 21 Code of Federal Regulations sec. 807.87
iii ibid, 807
iv ibid, 860.3(c)(2) & (3)
v ibid, 807.92
Esthetic devices are becoming more popular in salons, medi-spas, and medical clinics. The use of microdermabrasion, light-emitting diodes (LED), intense pulsed light (IPL), and laser therapies is growing. Though many medical devices are marketed for esthetic purposes, it is important to understand the regulation of esthetic devices, especially as it governs who can legally use them.
The Role of the FDA
What many people do not realize is that esthetic devices are regulated by the U.S. Food and Drug Administration (FDA). The FDA defines a medical device as "an instrument, apparatus, implement, or machine intended to affect the structure or any function of the body of man or other animal ..."i Given that esthetic devices are intended to affect the structure or function of the human body, the FDA requires registration of electrolysis, galvanic, microdermabrasion, IPL, and laser esthetic devices.
The FDA uses three classifications for medical devices:
Class I--Simple design and minimum potential for harm to user.
Class II--General controls alone are insufficient to assure safety and effectiveness, but existing methods are available to provide such assurances.
Class III--Devices where insufficient information exists to assure safety and effectiveness solely through controls.
Classification of Esthetic Devices
Some examples of class I medical items registered with the FDA are electrolysis, microdermabrasion, and galvanic devices. Class II examples include ultrasound, IPL, and laser devices.
One device that causes some confusion as to its classification is the LED. LED can be either a class I or II device depending on whether machines use red or blue light, implement ultraviolet or infrared radiation, what the range of the device's wavelengths are, and the device's intended use. Given the variations in LED devices, it's important to verify their classification with the FDA.
General Controls for Devices
The FDA requires general controls for class I, II, and III devices. The following general controls apply to all classes:ii
- 510(k) exempt.
- Establishment registration.
- Good manufacturing practices.
- Medical device listing.
- Proper labeling.
Good manufacturing practices ensure esthetic manufacturers are using machine parts and manufacturing practices that make safe machines. The establishment registration with the FDA refers to a requirement that organizations involved in the production and distribution of medical devices meant to be marketed or leased in the United States provide the FDA with the location of medical-device manufacturing facilities and importers.iii This includes manufacturers, initial importers, foreign establishments, and distributors. Unfortunately, it is not uncommon for devices to be imported illegally or manufactured illegally in the United States and sold to the beauty industry.
Using the Establishment Registration
The establishment registration provides a way for estheticians and physicians to ensure a machine is lawful and safe. Before you buy any esthetic device, make sure you obtain and verify the establishment registration. The seller can provide this number, and you can verify the registration on the FDA website: www.fda.gov/cdrh.
Manufacturers sell products under different names or register new products under a group of existing products. The surest way to verify registration is to have the seller provide the establishment number and then enter that registration on the FDA website. Otherwise, results are only as good as your search, which can be inconclusive at best.
Special Controls for Class II Devices
In addition to general controls applicable to all machines, class II and III devices require a 510(k) filing on premarket notification of intended use, mandatory performance standards, and post-market surveillance.iv Intended use is an important concept since it requires sale of the devices to physicians or other licensed professionals as prescriptive devices.v This is where estheticians can get in trouble with state cosmetology and medical boards. Who determines which licensed practitioners can use class II devices? Some think it should fall on the FDA, but the FDA relies on individual states to make this determination. Thus, it is up to state cosmetology and medical boards to decide whether class II devices can be independently operated by licensed estheticians or cosmetologists.
State Regulation of Esthetic Devices
FDA classification and registration requirements are complex and have made it difficult for cosmetology and medical boards to regulate use of such devices. States have tried a variety of approaches to provide some clear guidance to estheticians and physicians. In Colorado and Washington, for example, cosmetology rules--in conjunction with medical board regulations pertaining to supervision and delegation--permit licensed estheticians and cosmetologists to use any class I device. Estheticians and cosmetologists can use class II devices, such as lasers, but only under a licensed physician's delegation. All devices, regardless of classification, must be properly registered with the FDA. The use of unregistered devices is a violation in itself.
State Approaches Differ
An esthetician in Colorado or Washington who uses a class II device without medical delegation risks being disciplined by the cosmetology board, sued by the medical board for practicing medicine without a license, and criminally charged for impersonating a physician.
Oregon and Iowa have similar policies, but with some looser restrictions for class II devices. Licensed estheticians and cosmetologists in Oregon can use any class I and II devices. However, estheticians can only use class II devices within their intended use related to the practice of esthetics. This is where the 510(k) filing becomes important, as it details the intended use. So long as estheticians are using the class II devices within their intended use, the operation of the device is legal. This includes the use of lasers and IPL by estheticians. If estheticians use the devices beyond their intended scope, it constitutes the unlicensed practice of medicine and is subject to a variety of penalties.
California takes a different approach. Physicians may use such class II devices as lasers or IPL devices. Physician assistants and registered nurses may perform these treatments under a physician's supervision. Unlicensed medical assistants, cosmetologists, electrologists, and estheticians may not legally perform these treatments under any circumstances, nor may registered nurses or physician assistants perform them without supervision.
Do Your Homework
States take a variety of approaches to the regulation and use of esthetic devices. Before purchasing an expensive machine, it is important to make sure using the device is within your scope of practice. Contact your state medical and cosmetology boards. Once you determine that use of the machine is permissible, make sure the machine is lawfully registered with the FDA. Taking these steps will keep you within your legal scope of practice and promote safe esthetic practices. Otherwise, you are risking your client's safety and your livelihood.
* * *
Kevin D. Heupel is a licensed attorney specializing in beauty and salon legal issues and is the former director of the Colorado Office of Cosmetology. For more information: www.heupellaw.com or www.scec.biz.
Notes
i U.S. Federal Food, Drug, and Cosmetic Act sec. 201(h)
iiTitle 21, U.S. Congress, sec. 360c, 21 Code of Federal Regulations sec. 807.87
iii ibid, 807
iv ibid, 860.3(c)(2) & (3)
v ibid, 807.92
