NVK · Laser, Dental, Soft Tissue
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | NVK |
|---|---|
| Device Name | Laser, Dental, Soft Tissue |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Classification Rationale
(1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260765 | Gemini NOVA 810+980 Soft Tissue Laser | Azena Medical, LLC | Mar 10, 2026 | SESE |
| K250731 | MateLaser Medical Diode Laser Systems (ML-DLS-30) | Matelaser, Inc. | Oct 16, 2025 | SESE |
| K243764 | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) | Wuhan Pioon Technology Co., Ltd. | May 8, 2025 | SESE |
| K230047 | Medical Diode Laser Systems | Gigaalaser Company , Ltd. | Mar 4, 2024 | SESE |
| K232885 | Dawn Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | Feb 28, 2024 | SESE |
| K232222 | Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) | Medency S.R.L. | Nov 27, 2023 | SESE |
| K221761 | Solea | Convergent Dental, Inc. | Sep 14, 2022 | SESE |
| K211150 | Dental diode laser, SOGA Laser, ILaser II | Shenzhen Soga Technology Co., Ltd. | Jul 1, 2022 | SESE |
| K214008 | Dental diode laser | Shenzhen Soga Technology Co., Ltd. | May 10, 2022 | SESE |
| K213658 | DEKA SMARTPERIO | El.En Electronic Engineering Spa | Mar 11, 2022 | SESE |
| K210367 | D-Laser Blue, D-Laser 16 | Guilin Woodpecker Medical Instrument Co., Ltd. | Mar 10, 2022 | SESE |
| K213428 | EdgePro | Biolase, Inc. | Dec 22, 2021 | SESE |
| K210350 | Gemini 2 810+980 Soft Tissue Laser | Azena Medical, LLC | Nov 18, 2021 | SESE |
| K203396 | DEKA SMARTPERIO | El.En Electronic Engineering Spa | Aug 23, 2021 | SESE |
| K201387 | Ultrafast, Ultrafast Plus, Ultrafast Lite | Dentlight, Inc. | Feb 26, 2021 | SESE |
| K030146 | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ | Kavo America | Aug 3, 2005 | SESE |
Top Applicants
- Azena Medical, LLC — 2 clearances
- El.En Electronic Engineering Spa — 2 clearances
- Shenzhen Soga Technology Co., Ltd. — 2 clearances
- Biolase, Inc. — 1 clearance
- Convergent Dental, Inc. — 1 clearance
