Understanding Esthetic Devices

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Most people assume if a manufacturer is advertising in trade magazines and exhibiting at trade-shows, the equpment they sell or manufacture must be suitable for use by estheticians.  This isn't always the case.  You must take responsibility for protecting yourself and your business from the legal ramifications of operating an inappropriate device, or marketing/offering a service that is outside of your scope of practice as defined by your local laws.

 

There are three major categories of classification: 1, 2, and 3.  Most of the devices in the home and esthetic industry are Class 1 and 2.  Items such as: personal massagers, microcurrent facial toning devices, and microdermabrasion systems are all Class 1.  Laser hair removal in most cases are Class 2, and laser resurfacing, heart difibularoes and pacemakers would be good examples of Class 3 devices.  The classifications are typically defined by intended use, invasiveness, and the level of public risk the device poses.

Class 1 devices are almost always allowed to be used without medical supervision and are often marketed directly to end consumers.  On the other hand, the indended use statment of Class 2 and 3 devices note that they are to be sold under, or used by a licensed physician or licensed practitioner.  The term licensed practitioner is positioned so that each state can define their interpretation depending on the current structure of their licensures.  What may be allowed in one state may not be allowed in another.  Always check with your state board to ensure your state license covers the use of desired esthetic equpment.

 

A 510K is a FDA registration number that means the device has been evaluated by the FDA and has demonstarted substantial equivalency to that of another existing legally marketed device.  Note: any Class 1 equpment, does not have to be 510K registered.

 

There are 3 Key Components to Every Medical device:

1. 510K number
2. Classification
3. Intended use

Class 1 devices are typically exempt from 510K submissions due to their low risk and non-invasive nature.  Keeping this in mind, manufacturers who only manufacture Class 1 devices will not be able to supply a 510K, however they are still required to be registered with the FDA.

 

THE MANUFACTURER

Are they registered with the FDA?

Regardless of classification of device, every manufacturer, domestic or international, is required by federal law to be registered with the US FDA and declare what kind of devices they manufacture.  The statement "We do not make medical claims and therfore we do not have to deal with the FDA" is simply not true!  Check that the device you are considering is manufactured legally under the general controls set forth by the FDA Good Manufacturing Practices http://www.fda.gov/cdrh/devadvice/32.html.

 

Do they have Product Liablility Insurance?

Check that the manufacturer has Product Liability Insurance.  This is to ensure coverage and protection for individuals and companies who use products and devices manufactured by them.  This insurance provides coverage in the event that a product or device fails or malfunctions causing damage or harm.

 

Are they ISO 13485:2003 certified?

ISO is the International Organization for Standardization (Editors note: yes, I know it looks like it should be IOS, but it's not).  For consumers ISO ensures conformity of products and services.  ISO 13485:2003 is a certification that was specifically developed for medical device manufacturers and mirrors the rules set forth by the FDA Good Manufacturing Practices.  Although ISO certification is not federally mandated by the FDA, most manufacturers of class 1 devices are not consistently inspected by the FDA, wheras ISO performs inspections twice a year. http://www.iso.org/iso/catalogue_detail?csnumber=36786

 

Do they provide traning?

Before investing in the latest technology, ensure the manufacturr provides ongoing equipment training and field support.

THE DEVICE

Does the device have the correct specifications?
The specification sheet of any device you are considering purchasing should declare the Class (1, 2 or 3), the Product Code, and the Commercial Name of the device.  Remember that every skin care device is considered a medical device and every manfacturer of medical devices is required to be registered with the FDA.  Because of their non-significant risk status, Class 1 devices are exempt from FDA 510K submission and therefore do not have an FDA 510K number.  Class 2 and 3 devices are required to have a 510K number and Class 3 devices may have a PMA (Premarket Approval) http://www.fda.gov/cdrh/devadvice/pma/  

Most skin care devices fall into the Class 1 category.  Some Class 2 devices may be able to be used by a skin therapist without the supervision of a Physician, however, anything Class 2 or higher should be closely reviewed along side of your State Board code or regulations.

Is the device UL safety certified?
UL (Underwriters Laboratories) is a trusted source across the globe for product compliance.  UL certification is extremely important in skin care, as Class 1 devices are exempt from FDA 510K submissions and therefore excape mandatory UL safety certification.  Class 2 devices require 510K submission, part of an FDA submission is required UL safety certification.  UL safety certifications can be verified at www.ul.com  UL Standards for safety can be viewed at http://www.ul.com/info/standard.htm .

THE STATE

Do you have your Cosmetology Code of Regulations?
One of the most important things to do when purchasing a new device is to obtain and study the Cosmetology and Esthetics Code of Regulations.  Each state is regulated independently and therfore you cannot always count on consistency among the codes from state to state.  The definition of esthetics by most code of regulations is similar to the state of California: "... beautifying the face, neck, arms or upper part of the human body, by means of hands, devices, apparatus, or appliances, with the use of cosmetic preparations, antiseptics, tonics, lotions, creams...".  In order to stay in compliance with state inspections, it is highly suggested that you keep the Verifications for your equipment for state inspectors to view.  Keep an Intended Use Statement from the manufacturer, as well as your education Certificate from the device manufacturer.

Insurance
It's an unfortunate, but established fact: we live in an age of litigation and no matter how remote the threat of a lawsuit may seem, it can and does happen to skni care professionals with alarmingfrequency.  Yet with the safety net of an easily-obtained insurance plan, you will have that all important peace of mind.

• General Liablity - covers damage to contents and injury to persons.
• Business Income Loss - covers expenses if the business is unable to operate for a period of time.
• Professional Liability - covers injury from services rendered.
• Workers' Compensation - covers injury to employees while working.

Associated Bodywork and Massage Professionals (ABMP) has been serving the massage profession since 1987 and currently provides over 31,000 esthetician and massage therapist members with professional liablity insurance, publiscations, and legislative advocay.  ABMP can be reached at 800-458-2267 or online at www.abmp.com.

 

Associated Skin Care Professionals (ASCP) is devoted solely to providing insurance and support for skin care professionals.  Launched by the same people who, starting twenty years ago, built ABMP, which now boasts the largest skin care membership of any association in the country. ASCP can be reached online at: http://www.ascpskincare.com/