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GEX

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

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RecordFirmDateBuilder
A.R.C. Laser Surgical Fibers and Probes (K161403)A.R.C Laser GmbH2016-08-16+ Add
Medilas H Laser Fibers (K161771)Dornier Medtech America, Inc.2016-07-28+ Add
Waterlase Express (K161669)Biolase, Inc.2016-07-28+ Add
DuraLazeTM HoLEP Laser Fiber (K153124)Medkey, LLC2016-07-26+ Add
PicoWay Laser System (K160607)Syneron Candela Corporation2016-07-05+ Add
Lite Touch (K152737)Focus Medical, LLC2016-06-29+ Add
ATOVEN-Reusable Laser Fiber (K152667)Diotech CO2016-06-09+ Add
Helios III (K152856)Laseroptek Co., Ltd.2016-06-02+ Add
O-pel Laser and families of probe delivery devices (K160012)Precise Light Surgical2016-06-02+ Add
PicoSure Workstation (K160480)Cynosure, Inc.2016-05-17+ Add
Alma Diode Tabletop Laser (K160952)Alma, Ltd.2016-05-05+ Add
ACCENTO / HWA Dual/Single laser (K160227)Bison Medical Co, Ltd.2016-04-22+ Add
SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber (K151855)Surgical Laser Incorporated2016-04-15+ Add
Superbium (K153229)Bios S.R.L.2016-04-12+ Add
Magma System (K153566)Formatk Systems , Ltd.2016-04-06+ Add
EVO platform (K160368)Quanta System Spa2016-04-05+ Add
PURE CRYOGEN (K153564)Air Liquide Healthcare America Corporation2016-03-29+ Add
Quanta System Surgical Laser fibers (K160513)Quanta System Spa2016-03-18+ Add
PerioLase Nd:YAG Pulsed Dental Laser System (K151763)Millennium Dental Technologies, Inc.2016-03-15+ Add
Family of CoolGlide Aesthetic Lasers (K153671)Cutera, Inc.2016-03-09+ Add
PicoWay Laser System (K153527)Syneron Candela Corporation2016-03-02+ Add
Novilase Laser Therapy System, Model LTS-2 (K160392)Novian Health, Inc.2016-02-26+ Add
SKIN CARE (K152736)C.I.S, Ltd.2016-02-25+ Add
V20 system (K152611)Viora , Ltd.2016-02-19+ Add
Tranberg CLS Laser Fiber (K151569)Clinical Laserthermia Systems, AB2016-02-12+ Add
Spirit Hair Removal laser Family (K153718)Active Optical Systems , Ltd.2016-02-12+ Add
DIODE LASER THERAPY SYSTEMS (K152898)Beijing Sincoheren Science and Tech. Development Co., Ltd.2016-02-09+ Add
NaturaLase CO2 Laser System (K152529)Focus Medical, LLC2016-02-04+ Add
Lustre PRO Light System (K143713)Ambicare Health, Ltd.2016-01-19+ Add
Medical Diode Laser Systems (K151890)Wuhan Gigaa Optronics Technology Co., Ltd.2015-12-23+ Add
RUBY STAR (K150997)Bison Medical Co, Ltd.2015-12-22+ Add
NeoLas (K150664)Sheaumann Laser, Inc.2015-12-22+ Add
Quanta Forte (K152714)Quanta System Spa2015-12-21+ Add
Laser Dock (K152636)Patient Pocket, LLC2015-12-17+ Add
MicroSpot Handpiece (K152153)Asclepion Laser Technologies GmbH2015-12-11+ Add
neoV980 & neoV1470 Diode Lasers (K152722)G.N.S Neolaser , Ltd.2015-12-08+ Add
EVO platform (K152012)Quanta System Spa2015-12-08+ Add
Adler MicroMed Laser Surgery Fibers (K152417)Adler Micromed, Inc.2015-12-01+ Add
Picasso Plus, Picasso Lite Plus (K152939)Amd Group, LLC2015-11-25+ Add
Lumenis Smart532 Laser System (K151109)Lumenis, Inc.2015-10-30+ Add
Guardian 1000 (K151629)Quanta System Spa2015-10-27+ Add
Medilas H RFID Laser Fibers (K152591)Dornier Medtech America, Inc.2015-10-08+ Add
Solea (K151306)Convergent Dental, Inc.2015-09-23+ Add
ELUMI 810 + 980 Soft Tissue Laser (K152032)Azena Medical, LLC2015-09-16+ Add
CO2RE System (K151655)Syneron Medical, Ltd.2015-09-15+ Add
MH01 (K152220)Quanta System Spa2015-09-03+ Add
NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module (K151473)Focus Medical, LLC2015-09-01+ Add
LightSheer Desire Light Laser System (K151947)Lumenis, Ltd.2015-08-12+ Add
VIKINI Diode Laser System (K151232)Ilooda Co,., Ltd.2015-08-06+ Add
Cortex Laser System (K150587)Cynosure, Inc. Dba Ellman2015-07-21+ Add
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (K150907)Ellipse A/S2015-07-07+ Add
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch (K151331)Lumenis, Ltd.2015-06-30+ Add
MCL 31 Dermablate (K150140)Asclepion Laser Technologies GmbH2015-06-05+ Add
LUMINA 24 (K140386)Rogers Sciences, Inc.2015-05-26+ Add
Noblex Long Pulse Alexandrite Laser (K143666)Finemec Co., Ltd.2015-04-23+ Add
Tranberg CLS Thermal Therapy System (K142216)Clinical Laserthermia Systems, AB2015-04-21+ Add
DIODE LASER HAIR REMOVAL SYSTEM (K142186)Shenzhen Gsd Tech Co., Ltd.2015-04-17+ Add
PicoWay Laser System (K150326)Candela Corporation2015-04-16+ Add
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS (K150516)El.En Electronic Engineering Spa2015-04-13+ Add
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (K143723)Fotona D.D.2015-04-09+ Add
CYMA (K150027)Whitecap Technologies, LLC2015-04-03+ Add
COOK HOLMIUM LASER FIBER (K133788)Cook Incorporated2015-03-18+ Add
The MeDioStar NeXT Family (K143519)Asclepion Laser Technologies GmbH2015-03-10+ Add
WATERLASE IPLUS S (K141975)Biolase, Inc.2015-03-05+ Add
Photonica Professional (K150336)Ward Photonics, LLC2015-02-24+ Add
Picosure Workstation (K143105)Cynosure, Inc.2015-02-23+ Add
NeuroBlate System (K143457)Monteris Medical, Inc.2015-02-19+ Add
Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family (K142924)Shaser, Inc.2015-02-13+ Add
ELUX 810 LASER (K141986)Equipmed North America, Inc.2015-01-30+ Add
MULTIPULSE TM+1470 (K133891)Asclepion Laser Technologies GmbH2015-01-30+ Add
SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS (K141511)Cynosure, Inc.2015-01-23+ Add
Lumenis M22 System (K142860)Lumenis, Ltd.2015-01-21+ Add
InMode Diolaze Device (K142952)Inmode MD , Ltd.2015-01-13+ Add
IFS ADVANCED FEMTOSECOND LASER SYSTEM (K141852)Amo Manufacturing USA, LLC2015-01-06+ Add
IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) (K143154)Iridex Corporation2015-01-02+ Add
NAVILAS LASER SYSTEM (K141851)Od-Os GmbH2015-01-02+ Add
ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) (K142638)Innovaquartz, LLC2014-12-19+ Add
V20 SYSTEM (K142093)Viora , Ltd.2014-11-14+ Add
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS (K140732)Candela Corp.2014-11-07+ Add
CUTERA PICOSECOND LASER SYSTEM (K140727)Cutera, Inc.2014-11-06+ Add
ADVANTAGE (K141555)Lutronic Corporation2014-11-06+ Add
NS3000 Holmium Laser System (K142286)New Star Lasers, Inc.2014-10-31+ Add
Pico Way Laser System (K142372)Candela Corpation2014-10-30+ Add
DUAL SWITCH (K141908)Laser Engineering, Inc.2014-10-22+ Add
LIGHT SCALPEL (K141658)Lightscalpel, LLC2014-10-22+ Add
OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER (K140470)Oberon GmbH Fiber Technologies2014-10-15+ Add
MULTIPULSE HOPLUS (K131987)Asclepion Laser Technologies GmbH2014-10-15+ Add
AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch Procedure Kits (K142614)AngioDynamics, Inc.2014-10-10+ Add
EPIC 10 (K140120)Biolase, Inc.2014-10-10+ Add
LONG PULSE ND: YAG LASER SYSTEM (K140249)Advanced Technology Laser Co., Ltd.2014-10-08+ Add
DIODE LASER HAIR REMOVAL SYSTEM (K141973)Beijing Anchorfree Technology Co., Ltd.2014-10-06+ Add
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT (K140378)Omniguide, Inc.2014-09-25+ Add
LUCID LY (K140837)Bio-Med USA, Inc.2014-09-24+ Add
Palomar Icon Aesthetic System (K142376)Cynosure, Inc.2014-09-24+ Add
PICOSURE WORKSTATION (K140719)Cynosure, Inc.2014-09-22+ Add
Pilot Ultra Diode Laser (K142226)CAO Group, Inc.2014-09-12+ Add
Pilot Pro Diode Laser (K142223)CAO Group, Inc.2014-09-12+ Add
Pilot Elite Diode Laser (K142225)CAO Group, Inc.2014-09-12+ Add
ELITE + LASER SYSTEM (K141425)Cynosure, Inc.2014-09-11+ Add
DEKA SMARTXIDE LASER SYSTEM (K133895)El.En S.P.A.2014-09-05+ Add
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