Home › Device types › NVK
Laser, Dental, Soft Tissue
FDA product code NVK · Class 2 · General, Plastic Surgery
69
Registered devices
5
Adverse events
2
Recalls
17
510(k) clearances
Devices with this code
EdgePRO™ — US ENDODONTICS, LLCEdgePRO™ — US ENDODONTICS, LLCGemini EVO — AZENA MEDICAL, LLCEdgePRO™ — US ENDODONTICS, LLCEdgePRO™ — US ENDODONTICS, LLCWOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd.Primo Dental Laser — MEDENCY SRLLightwalker DT — FOTONA d.o.o.Picasso Pro Pre-initiated Laser Tip, 300um, 10mm — CAO GROUP, INC.Ultrafast Diode Laser — Dentlight Inc.Gemini EVO — AZENA MEDICAL, LLCGEMINI EVO — AZENA MEDICAL, LLCLightwalker AT — FOTONA d.o.o.Gemini EVO — AZENA MEDICAL, LLCLightwalker DT ADVANCED — FOTONA d.o.o.Lightwalker ST-E ADVANCED — FOTONA d.o.o.Picasso Pro Diode Laser — CAO GROUP, INC.DTE — Guilin Woodpecker Medical Instrument Co., Ltd.Lightwalker ST-E STAND — FOTONA d.o.o.EdgePRO™ — US ENDODONTICS, LLCPIOON — Wuhan Pioon Technology Co., Ltd.Primo Dental Laser — MEDENCY SRLPicasso Pro Pre-initiated Laser Tip, 300um, 5mm — CAO GROUP, INC.Picasso Pro Disposable Therapy Tip, Curved — CAO GROUP, INC.
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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