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/productcode/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 2866)

Showing 20 most recent of 2866 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260690](/device/K260690.md) | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | Jun 4, 2026 | SESE |
| [K260489](/device/K260489.md) | LASEmaR 1500 | Eufoton S.R.L. | May 29, 2026 | SESE |
| [K260138](/device/K260138.md) | LUNE PureHygiene | Enamel Pure | May 29, 2026 | SESE |
| [K253245](/device/K253245.md) | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | May 21, 2026 | SESE |
| [K260100](/device/K260100.md) | MOSES Raydar™ | Boston Scientific Corporation | May 18, 2026 | SESE |
| [K261214](/device/K261214.md) | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. | May 11, 2026 | SESE |
| [K260974](/device/K260974.md) | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | May 7, 2026 | SESE |
| [K260256](/device/K260256.md) | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | May 4, 2026 | SESE |
| [K253251](/device/K253251.md) | Leaseir MHR Xcell  (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) | Leaseir Technologies, Slu | May 4, 2026 | SESE |
| [K261094](/device/K261094.md) | YellowStar | Asclepion Laser Technologies GmbH | Apr 29, 2026 | SESE |
| [K253765](/device/K253765.md) | VANISH PRO | Ddc Technologies, Inc. | Apr 22, 2026 | SESE |
| [K260153](/device/K260153.md) | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | Apr 20, 2026 | SESE |
| [K260307](/device/K260307.md) | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | Apr 15, 2026 | SESE |
| [K260017](/device/K260017.md) | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | Apr 9, 2026 | SESE |
| [K260375](/device/K260375.md) | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | Mar 31, 2026 | SESE |
| [K260257](/device/K260257.md) | CO2 Laser System | Sanhe Meditech Co., Ltd. | Mar 28, 2026 | SESE |
| [K260632](/device/K260632.md) | LASER THERMAL THERAPY KIT | Elesta S.P.A | Mar 17, 2026 | SESE |
| [K252971](/device/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](/device/K254197.md) | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | Mar 11, 2026 | SESE |
| [K253951](/device/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 |

## Top Applicants

- Cynosure, Inc. — 80 clearances
- Sharplan Lasers, Inc. — 66 clearances
- Quanta System Spa — 57 clearances
- Laserscope — 49 clearances
- Trimedyne, Inc. — 48 clearances

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**Source:** [https://fda.innolitics.com/productcode/GEX](https://fda.innolitics.com/productcode/GEX)

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