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

Powered Laser Surgical Instrument

Regulation 878.4810

69510(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
Jun 2, 2023K231309SCAR 3
El.En Electroinc Engineering Spa, IT
GEX
Jun 1, 2023K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
Candela Corporation
GEX
May 26, 2023K230580Diode Laser System
Smedtrum Medical Technology Co., Ltd., TW
GEX
May 22, 2023K230460Laser Thermal Therapy Kit
Elesta S.P.A, IT
GEX
May 22, 2023K230373HELIOS 785 Pico
Laseroptek Co., Ltd., KR
GEX
May 4, 2023K230340Lucas Plus
Amt Engineering Co., Ltd., KR
GEX
Apr 27, 2023K222352Epildream HP 4000 MED
D.E.A Project S.R.1., IT
GEX
Apr 21, 2023K230819OmniGuide RFID Surgical Laser Fibers
Omni-Guide Holdings, Inc.
GEX
Mar 31, 2023K230274Medical Diode Laser (M2)
Wuhan Pioon Technology Co., Ltd., CN
GEX
Mar 31, 2023K223778Diode Laser Hair Removal System (RD-SLD600)
Shanghai Omni Laser Skinology Co., Ltd., CN
GEX
Mar 29, 2023K222485SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser
Ids, Limited, KR
GEX
Mar 15, 2023K222983NeuroBlate Fusion-S Software V3.17
Monteris Medical,
GEX
Mar 10, 2023K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
Gme German Medical Engineering GmbH, DE
GEX
Mar 1, 2023K230308Alma Harmony
Alma Lasers, Inc.
GEX
Feb 22, 2023K230371The Alma Soprano Titanium
Alma Lasers, Inc.
GEX
Feb 15, 2023K213669LIGHTSCALPEL LS-4020
Lightscalpel, Inc.
GEX
Feb 10, 2023K223680Eneka Pro
Termosalud, ES
GEX
Feb 1, 2023K222751LED Light Therapy Device, KN-7000L
Xuzhou Kernel Medical Equipment Co., Ltd., CN
GEX
Jan 27, 2023K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
Gyrus Acmi, Inc.
GEX
Jan 26, 2023K223588PALLAS Premium
Laseroptek Co., Ltd., KR
GEX
Jan 20, 2023K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
Quanta System Spa, IT
GEX
Jan 19, 2023K223540AvalancheLase Family
Fotona D.O.O., SI
GEX
Jan 4, 2023K223685SmoothCool HR System
Jeisys Medical, Inc., KR
GEX
Jan 4, 2023K222221DEKA HELIX
El.En Electronic Engineering Spa, IT
GEX
Dec 29, 2022K223647CLEAR+BRILLIANT TOUCH® Laser System
Solta Medical, Inc.
GEX
Dec 13, 2022K213105Epilaser Absolute
Epilady 2000, LLC, IL
GEX
Dec 9, 2022K222916US 450 Diode Laser Equipment
Beijing Globalipl Development Co., Ltd., CN
GEX
Nov 18, 2022K222701MANTA Laser
Squalus Med , Ltd., IL
GEX
Nov 17, 2022K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASE
Canadian Pioneer Medical Technology Corporation (Cpmt Laser), CA
GEX
Nov 17, 2022K222109Accure Laser
Accure Acne, Inc.
GEX
Nov 15, 2022K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS
Canadian Pioneer Medical Technology Corporation (Cpmt Laser), CA
GEX
Nov 7, 2022K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
Sanhe Laserconn Tech Co., Ltd., CN
GEX
Oct 13, 2022K220853PicoWay Laser System
Candela Corporation
GEX
Oct 12, 2022K222064The Alma Soprano Titanium
Alma Lasers, Inc.
GEX
Oct 12, 2022K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
Fotona D.O.O., SI
GEX
Oct 7, 2022K222369PURE Laser
Endymed Medical, Ltd., IL
GEX
Oct 3, 2022K202953Aurolase Therapy, Laser Delivery Device (LDD)
Nanospectra Biosciences, Inc.
GEX
Sep 25, 2022K222629Resonic Rapid Acoustic Pulse Device
Zeltiq Aesthetics, Inc.
GEX
Sep 23, 2022K222555reepot Nd; YAG laser system
Ilooda Co,., Ltd., KR
GEX
Sep 22, 2022K211605Dual Switch
Laser Engineering, Inc.
GEX
Sep 15, 2022K221597CO2 Laser System
Smedtrum Medical Technology Co., Ltd., TW
GEX
Sep 8, 2022K213267Dynamis Pro Family
Fotona D.O.O., SI
GEX
Sep 1, 2022K220531FOX 810, FOX 980
A.R.C Laser GmbH, DE
GEX
Aug 24, 2022K221427V-Laser
Wontech Co., Ltd., KR
GEX
Aug 23, 2022K220268Picosecond Laser System (Model PS10-A and PS10-B)
Beijing Adss Development Co., Ltd., CN
GEX
Aug 15, 2022K212790XLase Plus
Biotec Italia, Srl, IT
GEX
Aug 9, 2022K221789IRIS Pi Q switched Nd YAG laser
Bio-Med USA, Inc.
GEX
Jul 27, 2022K213252Dornier Thulio
Dornier Medtech America, Inc.
GEX
Jul 19, 2022K213761Joule diVa System
Sciton, Inc
GEX
Jul 14, 2022K212073Alma Diode Tabletop Laser
Alma Lasers , Ltd., IL
GEX

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