Data / Medical devices / Laser, Dental, Soft Tissue
Laser, Dental, Soft Tissue (NVK): 15 FDA-registered makers in 4 countries
15 establishments in 4 countries are registered with the FDA to make Laser, Dental, Soft Tissue (product code NVK, Class 2, 21 CFR 878.4810). 11 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on May 19, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NVK
- Device class
- 2
- Regulation
- 878.4810
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| China | 5 |
| Italy | 2 |
| Slovenia | 1 |
Makers of Laser, Dental, Soft Tissue
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Shenzhen Soga Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 3 | May 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| Azena Medical | Walnut Creek, CA, United States | Manufacturer, Specification developer | 2 | March 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| El.en. Electronic Engineering SPA | CALENZANO Firenze, Italy | Manufacturer | 2 | March 11, 2022 | 0 | 0 | 0 | api.fda.gov |
| Biolase MG LLC | Corona, CA, United States | Complaint file establishment, Manufacturer | 1 | December 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Biolase MG LLC | Foothill Ranch, CA, United States | Specification developer | 1 | December 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Convergent Dental | Waltham, MA, United States | Manufacturer | 1 | September 14, 2022 | 0 | 1 | 0 | api.fda.gov |
| Dentlight Inc. | Plano, TX, United States | Manufacturer | 1 | February 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Gigaalaser Company Ltd. | Wuhan Hubei, China | Manufacturer | 1 | March 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Guilin Woodpecker Medical Instrument Co., Ltd | GUILIN CITY Guangxi, China | Manufacturer | 1 | March 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Medency SRL | Vicenza Veneto, Italy | Complaint file establishment, Manufacturer, Specification developer | 1 | November 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Wonderful Opto-Electrics Tech. Co., Ltd | Shanghai, China | Manufacturer | 1 | February 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| All Quality & Services, Inc. | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cao (china) Medical Equipment Company, Limited | Langfang, Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cao Group, Inc. | W Jordan, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fotona D.O.O. | Ljubljana, Slovenia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.