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-staging.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 2880)

Showing 20 most recent of 2880 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K262426](/device/K262426.md) | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. | Sep 10, 2026 | SESE |
| [K261562](/device/K261562.md) | Diode Laser Therapy System | Sanhe LEFIS Electronics Co., Ltd. | Sep 10, 2026 | SESE |
| [K261589](/device/K261589.md) | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | Sep 2, 2026 | SESE |
| [K262269](/device/K262269.md) | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | Sep 1, 2026 | SESE |
| [K261821](/device/K261821.md) | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | Aug 27, 2026 | SESE |
| [K262070](/device/K262070.md) | Diode Laser Therapy Systems (DL612A) | Hebei Zollvan Medical Technology Co., Ltd. | Aug 19, 2026 | SESE |
| [K261964](/device/K261964.md) | ECHOLASER X4 | Elesta S.P.A | Aug 19, 2026 | SESE |
| [K261841](/device/K261841.md) | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | Aug 11, 2026 | SESE |
| [K261221](/device/K261221.md) | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | Jul 24, 2026 | SESE |
| [K261738](/device/K261738.md) | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | Jul 21, 2026 | SESE |
| [K261693](/device/K261693.md) | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. | Jul 17, 2026 | SESE |
| [K261674](/device/K261674.md) | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. | Jul 16, 2026 | SESE |
| [K261701](/device/K261701.md) | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. | Jun 18, 2026 | SESE |
| [K261570](/device/K261570.md) | PICOSURE WORKSTATION | Cynosure, LLC | Jun 17, 2026 | SESE |
| [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 |

## 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-staging.innolitics.com/productcode/GEX](https://fda-staging.innolitics.com/productcode/GEX)

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