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

Powered Laser Surgical Instrument

Regulation 878.4810

73510(k)s in 12 months (2,892 all time)
6recalls in 12 months (201 all time)
150recalls that name a 510(k)
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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
Oct 22, 2026K262701PicoPeak Picosecond Nd:Yag Laser System (Bella-9)
Beijing Sea Heart International Science and Technologyco.Ltd, CN
GEX
Oct 20, 2026K262628Picosecond Laser treatment system (Z180)
Sanhe PERFECTLASER Technology Co., Ltd., CN
GEX
Oct 13, 2026K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)
Keyue (Hangzhou) Medical Information Technology Co., Ltd., CN
GEX
Oct 8, 2026K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode L
Wuhan Phomed Technology Co., Ltd., CN
GEX
Oct 7, 2026K261692Diode Laser Hair Removal Machine (QDTM-03)
Beijing Nubway S&T Co., Ltd., CN
GEX
Sep 24, 2026K254199PicoreMax (PicoreMax)
BLUECORE COMPANY Co., Ltd., KR
GEX
Sep 19, 2026K252723Dynamis Pro Family
Fotona D.O.O., SI
GEX
Sep 19, 2026K241973SmartIPL_NI System
Lumenis Be, Ltd., IL
GEX
Sep 18, 2026K261047Dental Diode Laser Device (Laser-Pen)
Guilin Kevin Peter Technology Co., Ltd., CN
GEX
Sep 17, 2026K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)
Zhengzhou PZ Laser Slim Technology Co., Ltd., CN
GEX
Sep 17, 2026K261673LED Therapy Device (QLXY-01)
Beijing Nubway S&T Co., Ltd., CN
GEX
Sep 16, 2026K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Acc
Olympus Surgical Technologies America
GEX
Sep 10, 2026K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)
Wuhan Pioon Technology Co., Ltd., CN
GEX
Sep 10, 2026K261562Diode Laser Therapy System
Sanhe LEFIS Electronics Co., Ltd., CN
GEX
Sep 2, 2026K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)
Zhengzhou PZ Laser Slim Technology Co., Ltd., CN
GEX
Sep 1, 2026K262269CO2 Laser System (MBT- CO2 Laser)
Beijing Mega Beauty Technology Co., Ltd., CN
GEX
Aug 27, 2026K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)
Zhengzhou PZ Laser Slim Technology Co., Ltd., CN
GEX
Aug 19, 2026K262070Diode Laser Therapy Systems (DL612A)
Hebei Zollvan Medical Technology Co., Ltd., CN
GEX
Aug 19, 2026K261964ECHOLASER X4
Elesta S.P.A, IT
GEX
Aug 11, 2026K261841Q Switched Nd:YAG Laser machine (QLQW-01)
Beijing Nubway S&T Co., Ltd., CN
GEX
Jul 24, 2026K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Acc
Olympus Surgical Technologies America
GEX
Jul 21, 2026K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)
Rhein Laser Technologies Co., Ltd., CN
GEX
Jul 17, 2026K261693Diode laser hair removal machine (QDTM-04)
Beijing Nubway S&T Co., Ltd., CN
GEX
Jul 16, 2026K261674Skin Air Cooling System (QALF-01)
Beijing Nubway S&T Co., Ltd., CN
GEX
Jun 18, 2026K261701Hemolase 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., CN
GEX
Jun 17, 2026K261570PICOSURE WORKSTATION
Cynosure, LLC
GEX
Jun 4, 2026K260690LumiGlam Laser System (SHE-LSP601-3)
Beijing Sano Laser S&T Development Co.,Ltd, CN
GEX
May 29, 2026K260489LASEmaR 1500
Eufoton S.R.L., IT
GEX
May 29, 2026K260138LUNE PureHygiene
Enamel Pure
GEX
May 21, 2026K253245Boston 2910 (Boston 2910)
Boston Aesthetics, Inc.
GEX
May 18, 2026K260100MOSES Raydar™
Boston Scientific Corporation
GEX
May 11, 2026K261214PICO SHINING (PICO-K; PICOFY)
Speclipse, Inc., KR
GEX
May 7, 2026K260974CO2 Laser Machine (Monica-I,Monica-II)
Nanjing Bestview Laser S&T Co., Ltd., CN
GEX
May 4, 2026K260256Q-Switched Nd: YAG Laser Systems
Shanghai Apolo Medical Technology Co., Ltd., CN
GEX
May 4, 2026K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)
Leaseir Technologies, Slu, ES
GEX
Apr 29, 2026K261094YellowStar
Asclepion Laser Technologies GmbH, DE
GEX
Apr 22, 2026K253765VANISH PRO
Ddc Technologies, Inc.
GEX
Apr 20, 2026K260153Q-Switched Nd: YAG Laser System (Glamor Q)
Nanjing Bestview Laser S&T Co., Ltd., CN
GEX
Apr 15, 2026K260307Diode Laser Therapy Systems (V19)
Weifang Mingliang Electronics Co., Ltd., CN
GEX
Apr 9, 2026K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)
Shanghai Apolo Medical Technology Co., Ltd., CN
GEX
Mar 31, 2026K260375Nd: YAG Laser Therapy Systems
Sanhe Meditech Co., Ltd., CN
GEX
Mar 28, 2026K260257CO2 Laser System
Sanhe Meditech Co., Ltd., CN
GEX
Mar 17, 2026K260632LASER THERMAL THERAPY KIT
Elesta S.P.A, IT
GEX
Mar 17, 2026K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
C.R. Bard, Inc.
GEX
Mar 11, 2026K254197Picasso Pro Diode Laser (002-00460)
CAO Group, Inc.
GEX
Mar 6, 2026K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Appara
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., CN
GEX
Mar 3, 2026K253920CO2 Laser Treatment Machine (CFR3M1)
Haidari Beauty Technology (Beijing) Co., Ltd., CN
GEX
Feb 27, 2026K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
Beijing HuaCheng Taike Technology Co., Ltd., CN
GEX
Feb 27, 2026K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
Beijing HuaCheng Taike Technology Co., Ltd., CN
GEX
Feb 26, 2026K254271CAPRI
ORO Co., Ltd., KR
GEX

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