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GEX

2,872 FDA 510(k) clearances · Product code

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RecordFirmDate
Stellar M22 (K250809)Lumenis Be, Ltd.2025-04-16
Alma Harmony (K243044)Alma Lasers, Inc.2025-04-11
Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) (K250656)Wuhan Pioon Technology Co., Ltd.2025-04-04
AdvaTx (K250189)Advalight Aps2025-04-01
Medical Diode Laser Systems (THEIA808) (K250018)Gigaalaser Company , Ltd.2025-04-01
Medical Laser System Incanto / Evoline Platinum /Evoline (K243630)Solar LS Cjsc2025-03-21
Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (K241791)Gigaalaser Company , Ltd.2025-03-19
neoLaser Laser Surgery Fibers (K250113)G.N.S Neolaser , Ltd.2025-03-13
Photon Therapy Apparatus (BL-10) (K243993)Xemis Medical Technology (Shenzhen) Co., Ltd.2025-03-13
PICOALEX (K243957)Wontech Co., Ltd.2025-03-12
NOABLE LASER (K242207)Daeju Meditech Engineering Co., Ltd.2025-03-07
Q Switched Nd:YAG Laser machine (QNHF-01) (K242943)Beijing Nubway S&T Co., Ltd.2025-03-03
Medical diode laser systems (CHARISMA, REGAL) (K234004)Reveal Lasers , Ltd.2025-02-20
Single Use CO2 Laser Fiber (HAF005001) (K243588)Quanta System Spa2025-02-19
Pastelle Pro (K241527)Wontech Co., Ltd.2025-02-14
WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) (K241643)Wontech Co., Ltd.2025-02-14
HELIOS 785 Pico (1754V2) (K243780)Laseroptek Co., Ltd.2025-02-07
Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate) (K243465)Guangzhou Chuang Zao Mei Technology Co., Ltd.2025-02-06
BTL-754 (K241270)BTL Industries, Inc.2025-01-30
CO2 Laser Therapy Systems (SHE-LSP003-1) (K242941)Beijing Sano Laser S&T Development Co.,Ltd2025-01-27
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) (K243445)Bios S.R.L.2024-12-30
Diode Laser System model Dawn-S (K243037)Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd2024-12-26
Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) (K243141)Jiangxi Medex Technology Co., Ltd.2024-12-26
SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5; (K243121)Jiangxi Medex Technology Co., Ltd.2024-12-22
LGO-Surgical Laser Fibers (K243147)Light Guide Optics International , Ltd.2024-12-21
Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) (K241670)Beijing Adss Development Co., Ltd.2024-12-20
HandPICO Fractional Laser Handpiece Tip (K242534)Vydence Medical2024-12-20
Thulium Fiber Laser (FiberLAZE+, FiberLAZE) (K242987)Allengers Global Healthcare Private Limited2024-12-17
Medical Thulium Fiber Laser Systems (UroFiber 60Q) (K242293)Rhein Laser Technologies Co., Ltd.2024-11-19
Diode laser Treatment System (K18) (K241498)Hebei Keylaser Sci-Tech Co.,Ltd2024-11-18
Veincare (K241930)Wontech Co., Ltd.2024-11-14
ORTIV (ORTIV-BL, ORTIV-WH) (K241646)Mvitro Co., Ltd.2024-11-01
Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) (K240543)Medency S.R.L.2024-10-24
Fractional CO2 Laser Therapy System (EXFU CO2) (K242183)Weifang Mingliang Electronics Co., Ltd.2024-10-23
FREDDO (K242132)Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda2024-10-18
Accure Laser System (K242035)Accure Acne, Inc.2024-10-11
Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT (K241092)Quanta System Spa2024-10-10
Lasya-Trinity (K241951)BLUECORE COMPANY Co., Ltd.2024-10-10
MEDIYAG (K231948)Medicreations, LLC2024-10-09
ACTIVO (K242206)Daeju Meditech Engineering Co., Ltd.2024-09-27
Diode Laser Hair Removal System (K241860)Beijing Winkonlaser Technology Limited2024-09-25
MTONE EVO (MTONE EVO) (K240604)M&T S.R.L.2024-09-20
Liftendo; Liftendo 2.0 (K241771)Medical San Indústria DE Equipamentos Médicos Ltda.2024-09-16
FoLix (K242349)Lumenis Be, Ltd.2024-09-09
COPRO 3 (K241672)Amt Engineering Co., Ltd.2024-09-06
Litho 60; Litho 100; Litho 150 (K242251)Quanta System Spa2024-09-03
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K242191)Olympus Surgical Technologies America2024-08-23
LightWalker Laser System Family (K242202)Fotona D.O.O.2024-08-23
Fraxel® FTX Laser System (K242142)Solta Medical2024-08-21
SUPER VELOCE (K241699)Ilooda Co,., Ltd.2024-08-13
Diode Laser Therapy Device (DF-DIODE LASER-S1) (K241547)Weifang Dragonfly Electronics Technology Co., Ltd.2024-08-13
Eneka Selectif (K241656)Termosalud2024-08-12
MEDIDIODE (K231950)Medicreations, LLC2024-08-09
Diode Laser Hair Removal System (MBT-Diode Laser) (K241642)Beijing Mega Beauty Technology Co., Ltd.2024-08-02
LED Light Therapy Device, ELIXIR MD™ (K241293)Yassen Wellness, LLC2024-07-08
Dermablate (K241600)Asclepion Laser Technologies GmbH2024-07-03
Lavieen (K241406)Wontech Co., Ltd.2024-06-28
Picosecond Nd:YAG Laser (PICOCAREMAJESTY) (K241144)Wontech Co., Ltd.2024-06-24
MOTUS PRO Family (K241459)El.En S.P.A.2024-06-21
IVYLASER Diode laser hair removal system (IVY-HR-Alloy) (K240611)Ivylaser (Beijing) Technology Co.,Ltd2024-06-20
Medical Diode Laser (M2-GK) (K240747)Wuhan Pioon Technology Co., Ltd.2024-06-17
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) (K241407)Bios S.R.L.2024-06-14
BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E (K241358)Sun Pharmaceutical Industries, Inc.2024-06-13
Picosecond Nd:YAG Laser System; PICO LEGEND (K233007)Ami, Inc.2024-06-12
Medical Diode Laser (S1Pro) (K240644)Wuhan Pioon Technology Co., Ltd.2024-06-10
Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) (K240222)Aesthetic Technology, Ltd.2024-06-04
InnoVoyce VYLO (K240159)Innovoyce2024-05-29
Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) (K240874)Theralaser Medtech (China) Co., Ltd.2024-05-28
Regenalase Laser System (K233344)Ipg Medical2024-05-28
Diode Laser Hair Removal System (SH-VD910) (K240520)Beijing Sea Heart International Science and Technologyco.Ltd2024-05-20
Multi-function Platform Systems (BL-M10) (K240474)Shanghai Bele Medical Technology Co.,Ltd2024-05-20
DEKA TORO (K240752)El.En S.P.A.2024-05-16
Picosecond Nd:YAG Laser Systems (BL-C10) (K240386)Shanghai Bele Medical Technology Co.,Ltd2024-05-16
UltraClear Laser System (N/A) (K233803)Acclaro Corporation2024-05-08
VaporMAX LDD; MOJo LDD; MegaJOULE LDD (K233157)Innovaquartz, LLC2024-05-03
ORskin Blue (K232858)Megabay S.A.2024-05-01
Picosecond Nd:YAG Laser System (K240118)Smedtrum Medical Technology Co., Ltd.2024-04-30
MeDioStar (K240816)Asclepion Laser Technologies GmbH2024-04-23
Co2 Laser System, Models: PureLase And VanLase (K232133)Cpmt Laser (Canadian Pioneer Medical Technology Corporation)2024-04-16
TitanPico Laser Workstation (PICO-450) (K233757)Rhein Laser Technologies Co., Ltd.2024-04-11
NIRVANA (K234057)El.En S.P.A.2024-04-10
LUNE™ PureHygiene (K234085)Enamel Pure2024-03-25
IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories (K232568)Ipg Medical Corporation2024-03-21
Medical Diode Laser (Model: L2) (K240179)Wuhan Pioon Technology Co., Ltd.2024-03-21
SMARTXIDE PRO (K240537)El.En S.P.A.2024-03-20
PICOANDY (Q-Switched Nd:YAG Laser) (K234104)Wontech Co., Ltd.2024-03-15
Smartxide Tetra Pro (K240497)El.En S.P.A.2024-03-12
EmoLED (v. 2-USA) (K240132)Emoled, Srl2024-03-12
Elite iQ PRO (M122K1) (K240396)Cynosure, LLC2024-03-08
MultiPulse HoPLUS (K231876)Asclepion Laser Technologies GmbH2024-02-22
Diode Laser Therapy System (K231896)Beijing Adss Development Co., Ltd.2024-02-20
Azure (K231514)Daeshin Enterprise Co., Ltd.2024-02-14
Alma Harmony (K233024)Alma Lasers, Inc.2024-02-08
Cryojet Plus (SHE-ACP001-1) (K233416)Beijing Sano Laser S&T Development Co.,Ltd2024-02-06
PiXel8-Reveal (K233143)Rohrer Aesthetics2024-02-02
Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) (K233756)Rhein Laser Technologies Co., Ltd.2024-02-02
Resonic Rapid Acoustic Pulse Device (K233804)Zeltiq Aesthetics, Inc.2024-02-01
DermRays Revive (K231910)Wuhan Lotuxs Technology Co., Ltd.2024-01-30
Epilaser Pro (K233224)Epilady 2000, LLC2024-01-27
FlashHeal 2 (FlashHeal 2.0) (K233077)Inwound Aps2024-01-18
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