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Light Based Over The Counter Wrinkle Reduction

FDA product code OHS · Class 2 · General, Plastic Surgery

351
Registered devices
100
Adverse events
4
Recalls
162
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2018-06-29Quasar Bio-Tech, Inc.Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
2018-06-29Quasar Bio-Tech, Inc.Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
2018-06-29Quasar Bio-Tech, Inc.Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
2008-06-18Sybaritic, IncSybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.