FDA 510(k) clearances: Lasers and flash lamps Beginning in 1976, the US Food and Drug Administration (FDA)
began requiring new medical devices to demonstrate they were substantially
equivalent to a product marketed before 1976. FDA classifies lasers
and flash lamps as follows:
- Device Classification Name: Laser instrument, surgical, powered
- Regulation Number: 878.4810
- Product Code: GEX
Product Code GEX
Lasers and flashlamps cleared for hair removal by FDA since 1976:
[1] The ThermaLight
device by Jennifer Maxx is cleared as equivalent to the D'Plume
Photoepilator by  Carol Block.
[2] The NaturaLase
device was cleared under the device name LT-100 by manufacturer
LORAD. This company no longer makes the LT-100.
Source: Releasable 510(k) Database (type in GEX under
Product Code to list all laser and accessory clearances)
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