Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) → NVK — Laser, Dental, Soft Tissue # NVK · Laser, Dental, Soft Tissue _General, Plastic Surgery · 21 CFR 878.4810 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK ## Overview - **Product Code:** NVK - **Device Name:** Laser, Dental, Soft Tissue - **Regulation:** [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K260765.md) | Gemini NOVA 810+980 Soft Tissue Laser | Azena Medical, LLC | Mar 10, 2026 | SESE | | [K250731](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K250731.md) | MateLaser Medical Diode Laser Systems (ML-DLS-30) | Matelaser, Inc. | Oct 16, 2025 | SESE | | [K243764](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K243764.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K230047.md) | Medical Diode Laser Systems | Gigaalaser Company , Ltd. | Mar 4, 2024 | SESE | | [K232885](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K232885.md) | Dawn Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | Feb 28, 2024 | SESE | | [K232222](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K232222.md) | Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) | Medency S.R.L. | Nov 27, 2023 | SESE | | [K221761](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K221761.md) | Solea | Convergent Dental, Inc. | Sep 14, 2022 | SESE | | [K211150](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K211150.md) | Dental diode laser, SOGA Laser, ILaser II | Shenzhen Soga Technology Co., Ltd. | Jul 1, 2022 | SESE | | [K214008](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K214008.md) | Dental diode laser | Shenzhen Soga Technology Co., Ltd. | May 10, 2022 | SESE | | [K213658](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K213658.md) | DEKA SMARTPERIO | El.En Electronic Engineering Spa | Mar 11, 2022 | SESE | | [K210367](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K210367.md) | D-Laser Blue, D-Laser 16 | Guilin Woodpecker Medical Instrument Co., Ltd. | Mar 10, 2022 | SESE | | [K213428](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K213428.md) | EdgePro | Biolase, Inc. | Dec 22, 2021 | SESE | | [K210350](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K210350.md) | Gemini 2 810+980 Soft Tissue Laser | Azena Medical, LLC | Nov 18, 2021 | SESE | | [K203396](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K203396.md) | DEKA SMARTPERIO | El.En Electronic Engineering Spa | Aug 23, 2021 | SESE | | [K201387](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K201387.md) | Ultrafast, Ultrafast Plus, Ultrafast Lite | Dentlight, Inc. | Feb 26, 2021 | SESE | | [K030146](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK/K030146.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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