Chrysalis Intelligence · Product Codes · GEX

GEX · Powered Laser Surgical Instrument

General, Plastic Surgery · 420 clearances · 194 unique sponsors

Device class
Class II
Regulation 878.4810
Total clearances
420
2020-01-03 → 2026-08-11
Last 12 months
73
Unique sponsors
194
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.
Medical specialty
General, Plastic Surgery
Review panel
SU
Regulation number
878.4810
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
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
Alma Lasers, Inc. 9 1 2025-09-24
Fotona D.O.O. 9 0 2024-08-23
El.En S.P.A. 8 0 2025-08-06
Asclepion Laser Technologies GmbH 8 2 2026-04-29
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
Wuhan Pioon Technology Co., Ltd. 6 0 2025-04-04
Beijing Nubway S&T Co., Ltd. 5 3 2026-08-11
El.En Electronic Engineering Spa 5 0 2023-01-04
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
Ilooda Co,., Ltd. 5 0 2024-08-13
Rhein Laser Technologies Co., Ltd. 4 1 2026-07-21
Soliton, Inc. 4 0 2021-11-05
Monteris Medical, Inc. 4 0 2023-12-08
Zhengzhou PZ Laser Slim Technology Co., Ltd. 4 1 2025-10-23
Candela Corporation 4 0 2023-06-01
Cynosure, LLC 4 1 2026-06-17
Boston Scientific Corporation 4 2 2026-05-18
Cutera, Inc. 4 0 2025-07-11
Lumenis Be, Ltd. 4 0 2025-04-16
Nanjing Bestview Laser S&T Co., Ltd. 4 3 2026-05-07
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.

CodeTypeDescriptionConfidenceRationale
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

DateK-numberSponsorDevice
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)
2026-05-18 K260100 Boston Scientific Corporation MOSES Raydar™
2026-05-11 K261214 Speclipse, Inc. PICO SHINING (PICO-K; PICOFY)
2026-05-07 K260974 Nanjing Bestview Laser S&T Co., Ltd. CO2 Laser Machine (Monica-I,Monica-II)
2026-05-04 K260256 Shanghai Apolo Medical Technology Co., Ltd. Q-Switched Nd: YAG Laser Systems
2026-05-04 K253251 Leaseir Technologies, Slu Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)
2026-04-29 K261094 Asclepion Laser Technologies GmbH YellowStar
2026-04-22 K253765 Ddc Technologies, Inc. VANISH PRO
2026-04-20 K260153 Nanjing Bestview Laser S&T Co., Ltd. Q-Switched Nd: YAG Laser System (Glamor Q)
2026-04-15 K260307 Weifang Mingliang Electronics Co., Ltd. Diode Laser Therapy Systems (V19)
2026-04-09 K260017 Shanghai Apolo Medical Technology Co., Ltd. Picosecond Nd:YAG Laser Systems (Model: HS-298)
2026-03-31 K260375 Sanhe Meditech Co., Ltd. Nd: YAG Laser Therapy Systems
2026-03-28 K260257 Sanhe Meditech Co., Ltd. CO2 Laser System
2026-03-17 K260632 Elesta S.P.A LASER THERMAL THERAPY KIT
2026-03-17 K252971 C.R. Bard, Inc. Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)