← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

NVK — Laser, Dental, Soft Tissue

Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4810
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K253309Shenzhen Soga Technology Co., Ltd. · 510k2026-05-19
K260765Azena Medical, LLC · 510k2026-03-10
K250731Matelaser, Inc. · 510k2025-10-16
K243764Wuhan Pioon Technology Co., Ltd. · 510k2025-05-08

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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