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GEMINI EVO
AZENA MEDICAL, LLC · Model 9127 · UDI-DI 00850010501130
1
510(k) clearances
5
Adverse events
2
Recalls
19
Facilities
Description
Refill/accessory for Gemini EVO laser handpiece shell
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-01 | Convergent Dental | It has been found that potential unintended laser activation can occur without foot pedal depression. |
| 2008-08-08 | Zap Lasers LLC | The SoftLase Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an emission delay, user guide labels and locations, and calibration procedures a |
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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.