ClearanceBrief
Panels › General, Plastic Surgery › Product code GEX · Class 2

Powered Laser Surgical Instrument

Regulation 878.4810

72510(k)s in 12 months (2,892 all time)
6recalls in 12 months (201 all time)
150recalls that name a 510(k)
Get daily alerts for GEXSample briefCSV

Top companies in GEX

Company510(k)sRecalls
Cynosure, Inc.841
Lumenis6011
Sharplan Lasers, Inc.660
Quanta System Spa576
Candela Corp.535
Laserscope490
Trimedyne, Inc.480
Heraeus Lasersonics, Inc.370
Surgical Laser Technologies, Inc.350
Boston Scientific1123
Decided510(k)Device and applicantCode
Feb 24, 2026K252599Diode Laser Therapy Systems (WLA-02)
Wingderm Electro-Optics , Ltd., CN
GEX
Feb 18, 2026K252561BTL-754FF
BTL Industries, Inc.
GEX
Feb 3, 2026K252048808nm semiconductor laser hair removal machine
Xi'An Taibo Electronic Technology Co., Ltd., CN
GEX
Jan 30, 2026K251981Boston PICO (Boston PICO)
Boston Aesthetics, Inc.
GEX
Jan 24, 2026K253633Holmium Laser Therapeutic Apparatus (HZ-40)
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., CN
GEX
Jan 24, 2026K252753Vydence Family of Lasers
Vydence Medical Industria E Commercio Ltda, BR
GEX
Jan 21, 2026K252369Boston Pico755
Boston Aesthetics, Inc.
GEX
Dec 24, 2025K253342PICO-K
Speclipse, Inc., KR
GEX
Dec 19, 2025K252877SANDRO Dual
Wontech Co., Ltd., KR
GEX
Dec 19, 2025K251077JOULE 1064nm System and Accessories
Sciton, Inc
GEX
Dec 19, 2025K250998CO2 Laser Therapy System (Model: LFS-D9U)
Sanhe Lefis Electronics Co., Ltd., CN
GEX
Dec 12, 2025K252745Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
Micro-Energy Medical Technology Co., Ltd., CN
GEX
Nov 28, 2025K252658Medical Diode Laser Systems (TR-B)
Baoding Te'Anzhou Electronic Technology Co., Ltd., CN
GEX
Nov 25, 2025K253344BELLUS-Q
Speclipse, Inc., KR
GEX
Nov 25, 2025K253219LeafPure-Echo (LM-LPNdA)
Shenzhen Leaflife Technology Co., Ltd., CN
GEX
Nov 24, 2025K252787Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., CN
GEX
Nov 24, 2025K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium L
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., CN
GEX
Nov 20, 2025K253123CuRAS hybrid
Classys, Inc., KR
GEX
Nov 20, 2025K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., CN
GEX
Nov 7, 2025K252564Medical Diode Laser Systems (VeinCure)
Baoding Te'Anzhou Electronic Technology Co., Ltd., CN
GEX
Nov 7, 2025K252519CO2 Laser Therapy System (K106)
Hebei Keylaser Sci-Tech Co.,Ltd, CN
GEX
Nov 6, 2025K252515Q-Switched Nd:Yag laser (K690)
Hebei Keylaser Sci-Tech Co.,Ltd, CN
GEX
Nov 4, 2025K251303Tamburo Thulium Fiber Laser System
Menovex Medical Technology (Shenzhen) Co., Ltd., CN
GEX
Oct 31, 2025K252427Diode Laser Hair Removal Machine (GLD01)
Sanhe Meditech Co., Ltd., CN
GEX
Oct 30, 2025K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0
Boston Scientific Corporation
GEX
Oct 27, 2025K251824Patriot Duo
Patriot Laser, LLC
GEX
Oct 23, 2025K253100MultiPulse TFL
Asclepion Laser Technologies GmbH, DE
GEX
Oct 23, 2025K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
Zhengzhou PZ Laser Slim Technology Co., Ltd., CN
GEX
Oct 23, 2025K252345Picosecond Laser Device (PF131-BI)
Risu Medical Technology Co., Ltd., CN
GEX
Oct 20, 2025K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)
Sanhe Lefis Electronics Co., Ltd., CN
GEX
Oct 14, 2025K250776Lithoblast Single Use Holmium Laser Fibers
Dawell Medical, LLC
GEX
Oct 8, 2025K251699The Botticelli (Model: Athena)
Bellamia Technologies, Inc.
GEX
Oct 3, 2025K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
Jeisys Medical Incorporated, KR
GEX
Oct 3, 2025K242946HESTIA (L200-A)
Senbitec Co., Ltd., KR
GEX
Oct 1, 2025K252447Picosecond laser device (BMPS4)
Hebei Newangie Technology Co., Ltd., CN
GEX
Sep 26, 2025K251919Thulium Laser System (Deluxlase)
Nanjing Bestview Laser S&T Co., Ltd., CN
GEX
Sep 25, 2025K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLA
Wuhan Dimed Laser Technology Co., Ltd., CN
GEX
Sep 24, 2025K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
Alma Lasers, Inc.
GEX
Sep 19, 2025K251100IPGTFL-02
Ipg Medical Corporation
GEX
Sep 19, 2025K242859VEGA
Ibramed Equipamentos Médicos, BR
GEX
Sep 3, 2025K251457Diode laser therapy device (VADER)
Beijing Superlaser Technology Co., Ltd., CN
GEX
Aug 29, 2025K251727GLAM LED Facial Mask (TB-2386F)
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd., CN
GEX
Aug 26, 2025K250261Heager Medical Laser Family (Sabrina/Adolf)
Heager GmbH, DE
GEX
Aug 8, 2025K251801Diode laser device (BM091)
Hebei Newangie Technology Co., Ltd., CN
GEX
Aug 6, 2025K251432Olo
El.En S.P.A., IT
GEX
Jul 30, 2025K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
Shenzhen Lifotronic Technology Co., Ltd., CN
GEX
Jul 25, 2025K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
Zhengzhou PZ Laser Slim Technology Co., Ltd., CN
GEX
Jul 14, 2025K250504Leonardo Duster
Ceramoptec GmbH, DE
GEX
Jul 11, 2025K251149AviClear Laser System
Cutera, Inc.
GEX
Jul 9, 2025K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Las
Boston Scientific Corporation
GEX

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.