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Syneron: elos, eLight, eMax, & LipoLite > EMAX

Does anyone know tell me what the situation of emax on FDA? and what you guys think of this platform?
thanks

06.16 | Unregistered CommenterVANESSA

Vanessa,

The EMAX is currently not approved by the FDA. This means it is a violation of federal laws and regulations to possess, sell, transport, or use the unit within the US and other FDA jurisdictions. Though it is traditional for the FDA to give consumers a pass on recalled products, or products for which a warning letter is issued, it is ultimately the responsibility of the healthcare professional to know whether equipment they are using has the proper approvals. I know this can be deceiving given you are purchasing the unit from a prominent manufacturer, but as many as 25% of medical devices in many hospitals do not possess the proper approvals.

Here is a link to the warning letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm240669.htm

Your best bet is to watch for FDA notices, and stay away from the unit until it is approved. Regardless of the unit's efficacy, it is a red flag when a company refuses to undergo the proper approval procedures to market a device. Laser companies frequently violate 21 CFR 1040.10-11, and bypassing the FDA is a way to bypass this law which puts users and patients at risk.

Mickey

Hey mickey,

Do you know if this has been resolved with the eMax system or is it still without FDA approval? The issue date of this warning letter is dated about 8 months ago?

Cheers

K

08.24 | Unregistered CommenterKim

Hello Kim,

The FDA traditionally gives manufacturers about two years before it becomes an enforcement letter. Syneron will have to answer for every eMax sold, used, or caused an adverse event since issuance of the warning letter. The FDA process is streamlining, but they still have a way's to go. The Center for Devices and Radiological Health (CDRH), the section of the FDA that enforces x-ray and laser/light based devices recently appointed two ombudsmen to help streamline the complaints, warning, and enforcement process.

The biggest problem the FDA faces is 'we', that is, those of us in the field- users, technicians, and consumers- are the eyes and ears of the FDA. If we don't know what to report, where to look for reports, warning letters, and enforcement action, then we are often blind to what's 'right' or 'wrong' in our own field.

Currently, possession, sale, transport, or use of the eMax is a violation of various laws. It is unfortunate that this device is being marketed as if nothing is going on.

Another unit which may experience warning letters and/or enforcement action shortly is the Lumenis Lightsheer, which is marketed as a diode laser, and is nothing more than an IPL. Also the Hairmax Lasercomb, which is marketed as "FDA approved for home use". There is no such approval, and the Lasercomb is approved as a medical device to be used under the supervision of a physician just like any other laser or light based device.

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