GEX · Powered Laser Surgical Instrument
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | GEX |
|---|---|
| Device Name | Powered Laser Surgical Instrument |
| 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 (20 of 2854)
Showing 20 most recent of 2854 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260307 | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | Apr 15, 2026 | SESE |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | Apr 9, 2026 | SESE |
| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | Mar 31, 2026 | SESE |
| K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | Mar 28, 2026 | SESE |
| K260632 | LASER THERMAL THERAPY KIT | Elesta S.P.A | Mar 17, 2026 | SESE |
| K252971 | 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 | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | Mar 11, 2026 | SESE |
| K253951 | 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 | CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., Ltd. | Mar 3, 2026 | SESE |
| K253829 | Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) | Beijing HuaCheng Taike Technology Co., Ltd. | Feb 27, 2026 | SESE |
| K253828 | Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) | Beijing HuaCheng Taike Technology Co., Ltd. | Feb 27, 2026 | SESE |
| K254271 | CAPRI | ORO Co., Ltd. | Feb 26, 2026 | SESE |
| K252599 | Diode Laser Therapy Systems (WLA-02) | Wingderm Electro-Optics , Ltd. | Feb 24, 2026 | SESE |
| K252561 | BTL-754FF | BTL Industries, Inc. | Feb 18, 2026 | SESE |
| K252048 | 808nm semiconductor laser hair removal machine | Xi'An Taibo Electronic Technology Co., Ltd. | Feb 3, 2026 | SESE |
| K251981 | Boston PICO (Boston PICO) | Boston Aesthetics, Inc. | Jan 30, 2026 | SESE |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Jan 24, 2026 | SESE |
| K252753 | Vydence Family of Lasers | Vydence Medical Industria E Commercio Ltda | Jan 24, 2026 | SESE |
| K252369 | Boston Pico755 | Boston Aesthetics, Inc. | Jan 21, 2026 | SESE |
| K253342 | 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
