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Laser, Dental, Soft Tissue
FDA product code NVK · Class 2 · General, Plastic Surgery
92
Registered devices
5
Adverse events
2
Recalls
17
510(k) clearances
Devices with this code
EdgePRO™ — US ENDODONTICS, LLCLightwalker DT ADVANCED — FOTONA d.o.o.EdgePRO™ — US ENDODONTICS, LLCGIGAA — Gigaalaser Company Ltd.Picasso Pro Pre-initiated Laser Tip, 300um, 5mm — CAO GROUP, INC.EdgePRO™ — US ENDODONTICS, LLCEdgePRO™ — US ENDODONTICS, LLCEdgePRO™ — US ENDODONTICS, LLCPicasso Pro Pre-initiated Laser Tip, Variety Pack — CAO GROUP, INC.GIGAA — Gigaalaser Company Ltd.Picasso Pro Pre-initiated Laser Tip, 400um, 5mm — CAO GROUP, INC.Lightwalker DT — FOTONA d.o.o.GIGAA — Gigaalaser Company Ltd.Gemini Nova Domestic IFU - Replacement — AZENA MEDICAL, LLCGemini Nova Power Supply - US — AZENA MEDICAL, LLCLightwalker ST-E ADVANCED — FOTONA d.o.o.Nova 25mm PBM Adapter Cap - White — AZENA MEDICAL, LLCUltrafast Diode Laser — Dentlight Inc.Primo Dental Laser — MEDENCY SRLEdgePRO™ — US ENDODONTICS, LLCEdgePRO™ — US ENDODONTICS, LLCEdgePRO™ — US ENDODONTICS, LLCGemini Nova Laser Kit - DEMO — AZENA MEDICAL, LLCGemini EVO — AZENA MEDICAL, LLC
Recent 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 cali |
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