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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)
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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
Nov 14, 2024K241930Veincare
Wontech Co., Ltd., KR
GEX
Nov 1, 2024K241646ORTIV (ORTIV-BL, ORTIV-WH)
Mvitro Co., Ltd., KR
GEX
Oct 24, 2024K240543Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)
Medency S.R.L., IT
GEX
Oct 23, 2024K242183Fractional CO2 Laser Therapy System (EXFU CO2)
Weifang Mingliang Electronics Co., Ltd., CN
GEX
Oct 18, 2024K242132FREDDO
Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda, BR
GEX
Oct 11, 2024K242035Accure Laser System
Accure Acne, Inc.
GEX
Oct 10, 2024K241951Lasya-Trinity
BLUECORE COMPANY Co., Ltd., KR
GEX
Oct 10, 2024K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
Quanta System Spa, IT
GEX
Oct 9, 2024K231948MEDIYAG
Medicreations, LLC
GEX
Sep 27, 2024K242206ACTIVO
Daeju Meditech Engineering Co., Ltd., KR
GEX
Sep 25, 2024K241860Diode Laser Hair Removal System
Beijing Winkonlaser Technology Limited, CN
GEX
Sep 20, 2024K240604MTONE EVO (MTONE EVO)
M&T S.R.L., IT
GEX
Sep 16, 2024K241771Liftendo; Liftendo 2.0
Medical San Indústria DE Equipamentos Médicos Ltda., BR
GEX
Sep 9, 2024K242349FoLix
Lumenis Be, Ltd., IL
GEX
Sep 6, 2024K241672COPRO 3
Amt Engineering Co., Ltd., KR
GEX
Sep 3, 2024K242251Litho 60; Litho 100; Litho 150
Quanta System Spa, IT
GEX
Aug 23, 2024K242202LightWalker Laser System Family
Fotona D.O.O., SI
GEX
Aug 23, 2024K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Acc
Olympus Surgical Technologies America
GEX
Aug 21, 2024K242142Fraxel® FTX Laser System
Solta Medical
GEX
Aug 13, 2024K241699SUPER VELOCE
Ilooda Co,., Ltd., KR
GEX
Aug 13, 2024K241547Diode Laser Therapy Device (DF-DIODE LASER-S1)
Weifang Dragonfly Electronics Technology Co., Ltd., CN
GEX
Aug 12, 2024K241656Eneka Selectif
Termosalud, ES
GEX
Aug 9, 2024K231950MEDIDIODE
Medicreations, LLC
GEX
Aug 2, 2024K241642Diode Laser Hair Removal System (MBT-Diode Laser)
Beijing Mega Beauty Technology Co., Ltd., CN
GEX
Jul 8, 2024K241293LED Light Therapy Device, ELIXIR MD™
Yassen Wellness, LLC
GEX
Jul 3, 2024K241600Dermablate
Asclepion Laser Technologies GmbH, DE
GEX
Jun 28, 2024K241406Lavieen
Wontech Co., Ltd., KR
GEX
Jun 24, 2024K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
Wontech Co., Ltd., KR
GEX
Jun 21, 2024K241459MOTUS PRO Family
El.En S.P.A., IT
GEX
Jun 20, 2024K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)
Ivylaser (Beijing) Technology Co.,Ltd, CN
GEX
Jun 17, 2024K240747Medical Diode Laser (M2-GK)
Wuhan Pioon Technology Co., Ltd., CN
GEX
Jun 14, 2024K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
Bios S.R.L., IT
GEX
Jun 13, 2024K241358BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
Sun Pharmaceutical Industries, Inc.
GEX
Jun 12, 2024K233007Picosecond Nd:YAG Laser System; PICO LEGEND
Ami, Inc., KR
GEX
Jun 10, 2024K240644Medical Diode Laser (S1Pro)
Wuhan Pioon Technology Co., Ltd., CN
GEX
Jun 4, 2024K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)
Aesthetic Technology, Ltd., GB
GEX
May 29, 2024K240159InnoVoyce VYLO
Innovoyce
GEX
May 28, 2024K240874Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)
Theralaser Medtech (China) Co., Ltd., CN
GEX
May 28, 2024K233344Regenalase Laser System
Ipg Medical
GEX
May 20, 2024K240520Diode Laser Hair Removal System (SH-VD910)
Beijing Sea Heart International Science and Technologyco.Ltd, CN
GEX
May 20, 2024K240474Multi-function Platform Systems (BL-M10)
Shanghai Bele Medical Technology Co.,Ltd, CN
GEX
May 16, 2024K240752DEKA TORO
El.En S.P.A., IT
GEX
May 16, 2024K240386Picosecond Nd:YAG Laser Systems (BL-C10)
Shanghai Bele Medical Technology Co.,Ltd, CN
GEX
May 8, 2024K233803UltraClear Laser System (N/A)
Acclaro Corporation
GEX
May 3, 2024K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDD
Innovaquartz, LLC
GEX
May 1, 2024K232858ORskin Blue
Megabay S.A., AR
GEX
Apr 30, 2024K240118Picosecond Nd:YAG Laser System
Smedtrum Medical Technology Co., Ltd., TW
GEX
Apr 23, 2024K240816MeDioStar
Asclepion Laser Technologies GmbH, DE
GEX
Apr 16, 2024K232133Co2 Laser System, Models: PureLase And VanLase
Cpmt Laser (Canadian Pioneer Medical Technology Corporation), CA
GEX
Apr 11, 2024K233757TitanPico Laser Workstation (PICO-450)
Rhein Laser Technologies Co., Ltd., CN
GEX

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