Atlas FDA

GEX

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.

RecordFirmDateBuilder
CHEVEUX DIODE LASER SYSTEM (K100893)Sandstone Medical Technologies, LLC2010-06-16+ Add
FIBER ONE (K100746)American Medical Systems2010-06-11+ Add
OPTICAL INTEGRITY LASERGUARD FIBERS (K100194)Optical Integrity, Inc.2010-05-20+ Add
BWF-5 MEDICAL LASER SERIES (K093087)Litecure, LLC2010-05-12+ Add
ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM (K100415)Lumenis2010-04-21+ Add
FIBERLASE C02 LASER WAVEGUIDE (K100384)Lumenis, Ltd.2010-04-12+ Add
ARTISAN AESTHETIC SYSTEM (K100270)Palomar Medical Technologies, Inc.2010-03-29+ Add
D-STORM 810NM, D-STORM 980NM (K093048)Light Instruments2010-03-23+ Add
MODEL VISULAS 532S LASER WITH THE VITE OPTION (K100035)Carl Zeiss Meditec, AG2010-03-17+ Add
QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W (K100474)Quicklase Limited2010-03-16+ Add
EZLASE 3 LASER SYSTEM (K093852)Biolase Technology, Inc.2010-03-12+ Add
VERSAPULSE MODEL P20 LASER SYSTEM (K100228)Lumenis, Inc.2010-02-24+ Add
LS-40 CO2 LASER SYSTEM MODEL LS-40 (K093793)Sandstone Medical Technologies, LLC2010-02-18+ Add
MODIFIED STRAIGHT FIRE LASER FIBER (K100078)Boston Scientific Corp2010-02-12+ Add
VECTRA PLUS LASER SYSTEM AND ACCESSORIES (K082230)Xintec Corporation2010-02-03+ Add
FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID (K093162)Fotona D.D.2010-01-22+ Add
VARI-LASE ENDOVENOUS LASER CONSOLE (K093502)Vascular Solutions, Inc.2010-01-07+ Add
TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC (K090312)Tria Beauty, Inc.2010-01-05+ Add
LIGHTWAVE PROFESSIONAL DELUXE (K082586)Lightwave Technologies, LLC2010-01-04+ Add
TRIA HAIR REMOVAL LASER SYSTEM (K090820)Spectragenics, Inc.2009-12-23+ Add
COOLTOUCH VARIA ND:YAG LASER SYSTEM (K092964)New Star Lasers, Inc.2009-12-11+ Add
ACCUMAX (K093691)Boston Scientific Corp2009-12-11+ Add
WATERLASE MD, MODEL 7100102 (K091746)Biolase Technology, Inc.2009-12-07+ Add
SIROLASER ADVANCE (K092660)Sirona Dental Systems GmbH2009-12-03+ Add
MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES (K083123)Medart A/S2009-11-24+ Add
OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP (K093451)Omniguide, Inc.2009-11-20+ Add
PALOMAR LUX1540 HANDPIECE (K090195)Palomar Medical Technologies, Inc.2009-11-20+ Add
GREENLIGHT XPS LASER SYSTEM (K092735)American Medical Systems, Inc.2009-11-09+ Add
EPICARE-DUO LASER SYSTEM (K091625)Light Age, Inc.2009-11-03+ Add
ECO2 LASER SYSTEM (K091115)Lutronic Corporation2009-10-30+ Add
OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM (K093251)Omniguide, Inc.2009-10-29+ Add
PHOTEX30 DIODE LASER SERIES: 980, 810, 940 (K092197)Biotex, Inc.2009-10-06+ Add
WATERLASE MD (K083927)Biolase Technology, Inc.2009-10-01+ Add
LIPOEZE LASER ASSISTED ASPIRATION CANNULA (K091800)Curve Medical2009-09-23+ Add
DOCTOR SMILE A-810 AND B-980 LASERS (K091562)Lambda Scientific Spa2009-09-08+ Add
CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH (K091537)Cynosure, Inc.2009-09-03+ Add
LEDA (K090762)Quantel Derma GmbH2009-08-28+ Add
SPECTRA SP II, SPECTRA DENTA II (K091320)Lutronic Corporation2009-08-19+ Add
FOXQ 980 LASER (K091059)A.R.C Laser GmbH2009-08-13+ Add
ALMA LASERS ALEX755 MODULE (K090571)Alma Lasers , Ltd.2009-08-13+ Add
SOFTLASE PRO, ORTHOLASE AND HYGIENELASE (K091796)Zap Lasers, LLC2009-07-31+ Add
PASCAL PHOTOCOAGULATOR, PASCAL-US (K091666)Optimedica Corporation2009-07-15+ Add
WATERLASE C100, MODEL 7100104 (K091922)Biolase Technology, Inc.2009-07-14+ Add
LITHO LASER SYSTEM (K091909)Quanta System Spa2009-07-09+ Add
FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, (K090126)Fotona D.D.2009-06-29+ Add
CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER (K090164)Biolitec, Inc.2009-06-26+ Add
CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM (K090962)Quanta System Spa2009-06-19+ Add
VARI-LASE PLATINUM BRIGHT TIP LASER FIBER (K091551)Vascular Solutions, Inc.2009-06-19+ Add
PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS (K083616)Patholase, Inc.2009-06-12+ Add
MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) (K091323)Intermedic Arfran, SA2009-06-04+ Add
MEGAPULSE LASER SYSTEM AND FIBERS (K090776)Richard Wolf Medical Instruments Corp.2009-06-02+ Add
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM (K083899)Hoya Conbio, Inc.2009-06-01+ Add
ZELTIQ SYSTEM (K090094)Zeltiq Aesthetics2009-05-20+ Add
LOTUS II PULSED ER: YAG LASER SYSTEM (K083253)Laseroptek Co., Ltd.2009-05-15+ Add
ELITE MPX LASER SYSTEM WITH CRYO C (K091169)Cynosure, Inc.2009-05-13+ Add
LUME 2 SYSTEM, MODEL GA0005000 (K083733)Lumenis, Ltd.2009-05-04+ Add
MONTERIS MEDICAL AUTOLITT LASER PROBE (K081509)Monteris Medical,2009-05-01+ Add
HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM (K083203)Laseroptek Co., Ltd.2009-04-28+ Add
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY (K083889)Fotona D.D.2009-04-23+ Add
ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM (K083848)Alma Lasers , Ltd.2009-04-14+ Add
CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C (K090618)Cynosure, Inc.2009-04-14+ Add
BLUESHINE GOLD SERIES (K090297)Blueshine Srl2009-04-14+ Add
INCISIVE FAMILY OF INPULSE ND:YAG LASERS (K083215)Incisive, LLC2009-04-08+ Add
COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY (K090410)New Star Lasers, Inc.2009-03-27+ Add
SYNCHRO HP PLATFORM (K082039)El.En Electronic Engineering Spa2009-03-20+ Add
AFFIRM CO2 AND AFFIRM CO2 HP (K081424)Cynosure, Inc.2009-03-19+ Add
ELITE MPX LASER SYSTEM WITH XPL HANDPIECE (K090235)Cynosure, Inc.2009-03-17+ Add
SMOOTHLIPO (K083478)Eleme Medical, Inc.2009-03-17+ Add
PICASSO LASER SYSTEM (K083142)Amd Lasers, LLC2009-03-13+ Add
ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE (K090084)Merit Medical Systems, Inc.2009-03-06+ Add
ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES (K090281)Accutech Medical Technologies, Inc.2009-03-04+ Add
ERBIUM FRACTIONAL HANDPIECE (K083900)Palomar Medical Products, Inc.2009-02-27+ Add
DERMABLATE EFFECT (K081541)Asclepion Laser Technologies GmbH2009-02-23+ Add
PALOMAR ASPIRE LASER PLATFORM (K083165)Palomar Medical Products, Inc.2009-02-13+ Add
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE (K083500)Dornier Medtech America, Inc.2009-02-12+ Add
WATERLASE MD (K090181)Biolase Technology, Inc.2009-02-11+ Add
ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM (K082825)Energist, Ltd.2009-02-06+ Add
FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F (K083034)Fotona D.D.2009-02-04+ Add
MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM (K082407)Sandstone Medical Technologies, LLC2009-02-03+ Add
IPULSE, MODEL: I150 (K083748)Cyden Limited2009-02-02+ Add
ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 (K083918)Advanced Technology Laser Co., Ltd.2009-02-02+ Add
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE (K083258)Dornier Medtech America, Inc.2009-01-30+ Add
ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC (K083915)Advanced Technology Laser Co., Ltd.2009-01-29+ Add
CYNOSURE SMARTLIPO MPX LASER (K083795)Cynosure, Inc.2009-01-21+ Add
SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083 (K082409)Endophotonix, Inc.2009-01-21+ Add
MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS (K083082)Moor Instruments, Ltd.2009-01-13+ Add
ISOLAZ (K083730)Aesthera Corporation2009-01-09+ Add
180W CERELAS D 980NM DIODE LASER, MODEL D180 (K083682)Biolitec, Inc.2009-01-09+ Add
QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY (K083613)Quanta System Spa2008-12-23+ Add
NOVEON MODEL LS1100-03 (K083476)Nomir Medical Technologies, Inc.2008-12-22+ Add
EZLASE (K082938)Biolase Technology, Inc.2008-12-22+ Add
SMOOTHCOOL HR SYSTEM (K082911)Jeisys Medical, Inc.2008-12-19+ Add
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM (K082809)Lumenis, Inc.2008-12-18+ Add
SKINCLEAR Q-SWITCHED ND:YAG LASER (K083272)Global USA Distribution, LLC2008-12-16+ Add
CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE (K083379)Cynosure, Inc.2008-12-12+ Add
PROLITE III TOWER AND PR AND HR HANDPIECE (K081095)Quantel S.A.2008-12-12+ Add
15W CERALAS D 1470NM DIODE LASER, MODEL D1470 (K082225)Biolitec, Inc.2008-12-03+ Add
NO!NO! SKIN (K082423)Radiancy (Israel) , Ltd.2008-12-03+ Add
ULTRAWAVE III EX 1320 (K083207)Quanta System Spa2008-11-14+ Add
TANDA SKINCARE SYSTEM, MODEL: PTSCS (K080591)Pharos Life Corporation2008-11-14+ Add
← Previous Next →

Track GEX automatically

Every clearance here is in the API, with alerts when new ones post.