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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
Jul 12, 2022K221083Smartlux Mini
Medmix Co., Ltd., KR
GEX
Jun 30, 2022K221571InMode Multi-system
InMode , Ltd., IL
GEX
Jun 29, 2022K221312Diode Laser Hair Removal Device
Guangzhou Chuang Zao Mei Technology Co., Ltd., CN
GEX
Jun 28, 2022K213726PL-1 Skin Treatment System
AVAVA, Inc.
GEX
Jun 24, 2022K213250Secret Duo
Ilooda Co,., Ltd., KR
GEX
Jun 21, 2022K211979Lumenis Y&R Laser System
Lumenis, Inc.
GEX
Jun 9, 2022K212663HELIOS IV 785
Laseroptek Co., Ltd., KR
GEX
Jun 2, 2022K214049Leaseir MHR Xcell
Leaseir Technologies, Slu, ES
GEX
Jun 2, 2022K213261EpilME
Neauvia North America
GEX
May 25, 2022K220793InnoVoyce Laser Fiber
Innovoyce, LLC
GEX
May 20, 2022K220381Diode Laser Therapy Systems
Beijing Lasertell Medical Co., Ltd., CN
GEX
May 19, 2022K211534RevoLix HTL
Lisa Laser Products GmbH, DE
GEX
May 18, 2022K220467The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
Lumenis Be, Ltd., IL
GEX
May 5, 2022K220041HandPICO
Vydence Medical Industria E Comercio Ltda, BR
GEX
May 3, 2022K213594ECHOLASER X4
Elesta S.P.A, IT
GEX
Apr 29, 2022K220189LISA Laser Surgical Fibers
Omni-Guide Holdings, Inc.
GEX
Apr 22, 2022K213889PicoStar
Asclepion Laser Technologies GmbH, DE
GEX
Apr 21, 2022K210183Waterlase iPLus
Biolase, Inc.
GEX
Apr 20, 2022K213484SmoothCool HR System
Jeisys Medical, Inc., KR
GEX
Apr 15, 2022K213350mJOULE System and Accessories
Sciton, Inc
GEX
Apr 13, 2022K210634MCL 31 Dermablate System
Asclepion Laser Technologies GmbH, DE
GEX
Apr 12, 2022K220103LED Therapy Device (Planar LED/Planar LED mini)
Shenzhen Leaflife Technology Co., Ltd., CN
GEX
Apr 12, 2022K213557Finexel
SNJ Co., Ltd., KR
GEX
Mar 24, 2022K213461AviClear Laser System
Cutera, Inc.
GEX
Mar 16, 2022K220426Fiber Dust PRO
Quanta System Spa, IT
GEX
Feb 25, 2022K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
Canadian Pioneer Medical Technology Corporation, CA
GEX
Feb 4, 2022K220020Cryo 7
Zimmer Medizinsysteme GmbH, DE
GEX
Feb 4, 2022K213569HOLLYWOOD SPECTRA Laser System
Lutronic Corporation, KR
GEX
Feb 2, 2022K213554Sentient Manufacturing Laser Fiber
Sentient Manufacturing , LLC
GEX
Feb 2, 2022K211228Rosso
Quanta System Spa, IT
GEX
Feb 1, 2022K212611CO2 Laser Equipment
Beijing Globalipl Development Co., Ltd., CN
GEX
Jan 28, 2022K203395Platform treatment system
Shanghai Apolo Medical Technology Co., Ltd., CN
GEX
Jan 14, 2022K212478Dermatological diode laser system
Beijing Stelle Laser Technology Co., Ltd., CN
GEX
Jan 7, 2022K212127Picocaremajesty
Wontech Co., Ltd., KR
GEX
Dec 22, 2021K213225Diode Laser System GP900A8, Diode Laser System GP900Q8
Shenzhen Gsd Tech Co., Ltd., CN
GEX
Dec 20, 2021K212492Frax 1940 for Nordlys and Frax Pro
Candela Corporation
GEX
Dec 14, 2021K202848S2 Pigment Removal System
Lightsense Technologies, Ltd., GB
GEX
Dec 10, 2021K210847UltraClear Fractional Laser System
Fa International, LP
GEX
Dec 8, 2021K212573PicoLO Premium
Laseroptek Co., Ltd., KR
GEX
Dec 2, 2021K202175OxyLight 2.0
Raja Trading Company, Inc.
GEX
Nov 19, 2021K202288Finebeam
SNJ Co., Ltd., KR
GEX
Nov 15, 2021K212607Darwin
Luvo Medical Technologies, Inc., CA
GEX
Nov 10, 2021K212978Diode laser therapy system
Beijing Unt Technology Co., Ltd., CN
GEX
Nov 9, 2021K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Las
Convergent Laser Technologies
GEX
Nov 5, 2021K212502Resonic Rapid Acoustic Pulse Device
Soliton, Inc.
GEX
Oct 26, 2021K211977Medical Diode Laser Systems
Wuhan Dimed Laser Technology Co., Ltd., CN
GEX
Oct 26, 2021K202998Vydence Zye and Vydence One
Vydence Medical Industria E Comercio Ltda, BR
GEX
Oct 25, 2021K212793Laser Treatment System, Model: Hera, Armo
Canadian Pioneer Medical Technology Corporation, CA
GEX
Oct 22, 2021K211735CO2 Laser Machine, Model: BW-203B
Zhengzhou Bestview ST Co., Ltd., CN
GEX
Oct 21, 2021K212270DEKA LipoAI
El.En Electronic Engineering Spa, IT
GEX

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