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Omnilux CLEAR
I-SMART DEVELOPMENTS LIMITED · Model TN2112 · UDI-DI 05060534510234
1
510(k) clearances
51
Adverse events (1 deaths)
4
Recalls
117
Facilities
Description
Over-The-Counter Powered Light Based Laser For Acne- Omnilux CLEAR branded
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-04 | Accord Media, LLC | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
| 2017-12-04 | Accord Media, LLC | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
| 2017-12-04 | Accord Media, LLC | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
| 2017-12-04 | Accord Media, LLC | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.