FDA 510(k) clearance: Lasers and flash lamps

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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)