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) → GEX — Powered Laser Surgical Instrument # GEX · Powered Laser Surgical Instrument _General, Plastic Surgery · 21 CFR 878.4810 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX ## Overview - **Product Code:** GEX - **Device Name:** Powered Laser Surgical Instrument - **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 (20 of 2854) Showing 20 most recent of 2854 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260307](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K260307.md) | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | Apr 15, 2026 | SESE | | [K260017](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K260017.md) | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | Apr 9, 2026 | SESE | | [K260375](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K260375.md) | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | Mar 31, 2026 | SESE | | [K260257](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K260257.md) | CO2 Laser System | Sanhe Meditech Co., Ltd. | Mar 28, 2026 | SESE | | [K260632](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K260632.md) | LASER THERMAL THERAPY KIT | Elesta S.P.A | Mar 17, 2026 | SESE | | [K252971](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K252971.md) | Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. | Mar 17, 2026 | SESE | | [K254197](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K254197.md) | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | Mar 11, 2026 | SESE | | [K253951](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K253951.md) | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Mar 6, 2026 | SESE | | [K253920](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K253920.md) | CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., Ltd. | Mar 3, 2026 | SESE | | [K253829](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K253829.md) | Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) | Beijing HuaCheng Taike Technology Co., Ltd. | Feb 27, 2026 | SESE | | [K253828](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K253828.md) | Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) | Beijing HuaCheng Taike Technology Co., Ltd. | Feb 27, 2026 | SESE | | [K254271](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K254271.md) | CAPRI | ORO Co., Ltd. | Feb 26, 2026 | SESE | | [K252599](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K252599.md) | Diode Laser Therapy Systems (WLA-02) | Wingderm Electro-Optics , Ltd. | Feb 24, 2026 | SESE | | [K252561](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K252561.md) | BTL-754FF | BTL Industries, Inc. | Feb 18, 2026 | SESE | | [K252048](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K252048.md) | 808nm semiconductor laser hair removal machine | Xi'An Taibo Electronic Technology Co., Ltd. | Feb 3, 2026 | SESE | | [K251981](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K251981.md) | Boston PICO (Boston PICO) | Boston Aesthetics, Inc. | Jan 30, 2026 | SESE | | [K253633](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K253633.md) | Holmium Laser Therapeutic Apparatus (HZ-40) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Jan 24, 2026 | SESE | | [K252753](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K252753.md) | Vydence Family of Lasers | Vydence Medical Industria E Commercio Ltda | Jan 24, 2026 | SESE | | [K252369](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K252369.md) | Boston Pico755 | Boston Aesthetics, Inc. | Jan 21, 2026 | SESE | | [K253342](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K253342.md) | PICO-K | Speclipse, Inc. | Dec 24, 2025 | SESE | ## Top Applicants - Cynosure, Inc. — 80 clearances - Sharplan Lasers, Inc. — 66 clearances - Quanta System Spa — 57 clearances - Laserscope — 49 clearances - Trimedyne, Inc. — 48 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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