GEX · Powered Laser Surgical Instrument

Device class

Class II

Regulation 878.4810

Total clearances

434

2020-01-03 → 2026-09-24

Last 12 months

Unique sponsors

196

Definition

What is Powered Laser Surgical Instrument

A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4810

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Wontech Co., Ltd.	18	1	2025-12-19
Quanta System Spa	14	0	2025-06-06
Fotona D.O.O.	10	1	2026-09-19
Alma Lasers, Inc.	9	0	2025-09-24
Asclepion Laser Technologies GmbH	8	2	2026-04-29
El.En S.P.A.	8	0	2025-08-06
Wuhan Pioon Technology Co., Ltd.	7	1	2026-09-10
Zhengzhou PZ Laser Slim Technology Co., Ltd.	7	4	2026-09-17
Laseroptek Co., Ltd.	7	0	2025-02-07
Lumenis, Ltd.	6	0	2022-06-21
Shanghai Apolo Medical Technology Co., Ltd.	6	2	2026-05-04
Beijing Nubway S&T Co., Ltd.	6	4	2026-09-17
Ilooda Co,., Ltd.	5	0	2024-08-13
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.	5	5	2026-03-06
Beijing Sano Laser S&T Development Co.,Ltd	5	1	2026-06-04
El.En Electronic Engineering Spa	5	0	2023-01-04
Lumenis Be, Ltd.	5	1	2026-09-19
Cutera, Inc.	4	0	2025-07-11
Elesta S.P.A	4	2	2026-08-19
Boston Scientific Corporation	4	2	2026-05-18
Soliton, Inc.	4	0	2021-11-05
Candela Corporation	4	0	2023-06-01
Rhein Laser Technologies Co., Ltd.	4	1	2026-07-21
Nanjing Bestview Laser S&T Co., Ltd.	4	2	2026-05-07
Monteris Medical, Inc.	4	0	2023-12-08

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
17000	CPT	—	Medium	CPT for destruction of skin lesions by laser; laser surgical instrument billing depends on tissue type and indication
99070	CPT	—	Medium	Powered laser surgical instrument may be billed as supply depending on facility/reimbursement model

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-24	K254199	BLUECORE COMPANY Co., Ltd.	PicoreMax (PicoreMax)
2026-09-19	K252723	Fotona D.O.O.	Dynamis Pro Family
2026-09-19	K241973	Lumenis Be, Ltd.	SmartIPL_NI System
2026-09-18	K261047	Guilin Kevin Peter Technology Co., Ltd.	Dental Diode Laser Device (Laser-Pen)
2026-09-17	K261817	Zhengzhou PZ Laser Slim Technology Co., Ltd.	Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)
2026-09-17	K261673	Beijing Nubway S&T Co., Ltd.	LED Therapy Device (QLXY-01)
2026-09-16	K262877	Olympus Surgical Technologies America	SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
2026-09-10	K262426	Wuhan Pioon Technology Co., Ltd.	Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)
2026-09-10	K261562	Sanhe LEFIS Electronics Co., Ltd.	Diode Laser Therapy System
2026-09-02	K261589	Zhengzhou PZ Laser Slim Technology Co., Ltd.	1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)
2026-09-01	K262269	Beijing Mega Beauty Technology Co., Ltd.	CO2 Laser System (MBT- CO2 Laser)
2026-08-27	K261821	Zhengzhou PZ Laser Slim Technology Co., Ltd.	1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)
2026-08-19	K262070	Hebei Zollvan Medical Technology Co., Ltd.	Diode Laser Therapy Systems (DL612A)
2026-08-19	K261964	Elesta S.P.A	ECHOLASER X4
2026-08-11	K261841	Beijing Nubway S&T Co., Ltd.	Q Switched Nd:YAG Laser machine (QLQW-01)
2026-07-24	K261221	Olympus Surgical Technologies America	SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
2026-07-21	K261738	Rhein Laser Technologies Co., Ltd.	Medical Thulium Fiber Laser Systems (UroFiber 150Q)
2026-07-17	K261693	Beijing Nubway S&T Co., Ltd.	Diode laser hair removal machine (QDTM-04)
2026-07-16	K261674	Beijing Nubway S&T Co., Ltd.	Skin Air Cooling System (QALF-01)
2026-06-18	K261701	Micro-Energy Medical Technology Co., Ltd.	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)
2026-06-17	K261570	Cynosure, LLC	PICOSURE WORKSTATION
2026-06-04	K260690	Beijing Sano Laser S&T Development Co.,Ltd	LumiGlam Laser System (SHE-LSP601-3)
2026-05-29	K260489	Eufoton S.R.L.	LASEmaR 1500
2026-05-29	K260138	Enamel Pure	LUNE PureHygiene
2026-05-21	K253245	Boston Aesthetics, Inc.	Boston 2910 (Boston 2910)