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# FDA Clears Syneron Medical’s Profound Device
- URL: https://www.fdaweb.com/fda-clears-syneron-medicals-profound-device/
- Published: 2016-11-09T12:00:00.000Z
- Updated: 2026-09-14T21:46:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137298

FDA has given 510(k) clearance to Syneron Medical’s Profound fractional radiofrequency microneedling device for use with the 75˚ SubQ handpiece and cartridge to improve the appearance of cellulite in patients with Fitzpatrick skin types 1-3 as supported by long-term (six months) clinical data. The company says that a multi-center clinical study involving 50 women with Fitzpatrick skin types 1-3 showed improvement in cellulite severity (in dimples and/undulation irregularities) in 94% of treated thighs assessed at a three-month follow up. Sustained improvement was noted in 93% of the treated thighs at six-month follow-up, it says.