FDA Product Code
FDA Product Code GEX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 2,887 records · page 11 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K083082 | MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS | Moor Instruments, Ltd. | 2009-01-13 | Traditional | PDF ↗ |
| K083682 | 180W CERELAS D 980NM DIODE LASER, MODEL D180 | Biolitec, Inc. | 2009-01-09 | Special | PDF ↗ |
| K083730 | ISOLAZ | Aesthera Corporation | 2009-01-09 | Special | PDF ↗ |
| K083613 | QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY | Quanta System Spa | 2008-12-23 | Traditional | PDF ↗ |
| K082938 | EZLASE | Biolase Technology, Inc. | 2008-12-22 | Traditional | PDF ↗ |
| K083476 | NOVEON MODEL LS1100-03 | Nomir Medical Technologies, Inc. | 2008-12-22 | Special | PDF ↗ |
| K082911 | SMOOTHCOOL HR SYSTEM | Jeisys Medical, Inc. | 2008-12-19 | Traditional | PDF ↗ |
| K082809 | ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM | Lumenis, Inc. | 2008-12-18 | Traditional | PDF ↗ |
| K083272 | SKINCLEAR Q-SWITCHED ND:YAG LASER | Global USA Distribution, LLC | 2008-12-16 | Traditional | PDF ↗ |
| K083379 | CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE | Cynosure, Inc. | 2008-12-12 | Special | PDF ↗ |
| K081095 | PROLITE III TOWER AND PR AND HR HANDPIECE | Quantel S.A. | 2008-12-12 | Traditional | PDF ↗ |
| K082423 | NO!NO! SKIN | Radiancy (Israel) , Ltd. | 2008-12-03 | Traditional | PDF ↗ |
| K082225 | 15W CERALAS D 1470NM DIODE LASER, MODEL D1470 | Biolitec, Inc. | 2008-12-03 | Special | PDF ↗ |
| K083207 | ULTRAWAVE III EX 1320 | Quanta System Spa | 2008-11-14 | Traditional | PDF ↗ |
| K080591 | TANDA SKINCARE SYSTEM, MODEL: PTSCS | Pharos Life Corporation | 2008-11-14 | Traditional | PDF ↗ |
| K083069 | EZLASE 10W | Biolase Technology, Inc. | 2008-11-13 | Special | PDF ↗ |
| K082876 | BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY | Sharplight Technologies, Ltd. | 2008-11-10 | Traditional | PDF ↗ |
| K082101 | LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE | Sandstone Medical Technologies, LLC | 2008-11-05 | Traditional | PDF ↗ |
| K082721 | LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS | Photo Medex, Inc. | 2008-10-28 | Traditional | PDF ↗ |
| K082263 | CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 | Biolitec, Inc. | 2008-10-24 | Special | PDF ↗ |
| K081352 | PROFILE MULTI-PLATFORM SYSTEM | Sciton, Inc | 2008-10-23 | Traditional | PDF ↗ |
| K082298 | FLASH N' GO | Home Skinovations , Ltd. | 2008-10-23 | Traditional | PDF ↗ |
| K081408 | ELLIPSE MULTIFLEX | Ellipse A/S | 2008-10-17 | Traditional | PDF ↗ |
| K082928 | STRAIGHT FIRE HOLMIUM LASER FIBER | Boston Scientific Corp | 2008-10-16 | Traditional | PDF ↗ |
| K082232 | EVIS MD PLANTIUM BLUE | Ageless Beauty Corporation | 2008-10-15 | Traditional | PDF ↗ |
| K082445 | CURATIVE980 DIODE LASER | Oroscience, Inc. | 2008-10-15 | Traditional | PDF ↗ |
| K082247 | EVIS MD PLATINUM RED LIGHT THERAPY | Ageless Beauty Corporation | 2008-10-08 | Traditional | PDF ↗ |
| K082096 | POWERLIPO LASER SYSTEM | Lutronic Corporation | 2008-10-08 | Traditional | PDF ↗ |
| K073022 | CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830 | Clareblend, Inc. | 2008-10-01 | Traditional | PDF ↗ |
| K073000 | LUMAPROBE | Clareblend, Inc. | 2008-10-01 | Traditional | PDF ↗ |
| K082004 | SMOOTHKIT+ | Osyris | 2008-09-26 | Special | PDF ↗ |
| K080382 | SELLAS | Dinona Co., Ltd. | 2008-09-24 | Traditional | PDF ↗ |
| K073572 | MATRIX RF APPLICATOR | Syneron Medical, Ltd. | 2008-09-17 | Traditional | PDF ↗ |
| K080638 | CLARO | Clrs Technology Corporation | 2008-09-17 | Traditional | PDF ↗ |
| K081704 | SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS | Lumenis, Inc. | 2008-09-11 | Traditional | PDF ↗ |
| K081744 | PASCAL SYNTHESIS DELIVERY SYSTEM | Optimedica Corporation | 2008-09-09 | Traditional | PDF ↗ |
| K073317 | STARLIGHT, MODEL PD9012 | F.P. Rubinstein Y Cia S.R.L. | 2008-09-03 | Traditional | PDF ↗ |
| K081652 | CLAROS NANO DENTAL LASER SYSTEM | Elexxion AG | 2008-08-28 | Abbreviated | PDF ↗ |
| K073158 | SCULPTURE 2.94 ER:YAG SYSTEM | Hoya Conbio, Inc. | 2008-08-27 | Traditional | PDF ↗ |
| K073427 | MEDILAS D FAMILY LASERS | Dornier Medtech America, Inc. | 2008-08-20 | Traditional | PDF ↗ |
| K080530 | MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE | Cutera, Inc. | 2008-08-15 | Special | PDF ↗ |
| K081939 | OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY | Omniguide, Inc. | 2008-08-12 | Traditional | PDF ↗ |
| K082028 | LASERPEEL SOFT-MET MODIFIED ERBIUM LASER | Global USA Distribution, LLC | 2008-08-08 | Traditional | PDF ↗ |
| K081457 | ATRILAZE LASER ABLATION SYSTEM | Medical Cv, Inc. | 2008-08-08 | Traditional | PDF ↗ |
| K071687 | FAMILI OF IRIDEX IQ LASER SYSTEMS | Iridex Corp | 2008-08-07 | Traditional | PDF ↗ |
| K082033 | NANNOLIGHT INTENSE PULSED LIGHT SYSTEM | Global USA Distribution, LLC | 2008-07-31 | Traditional | PDF ↗ |
| K080463 | ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES | Alma Lasers , Ltd. | 2008-07-23 | Traditional | PDF ↗ |
| K081619 | CHROMOLITE EP | Chromogenex Technologies Limited | 2008-07-18 | Special | PDF ↗ |
| K080731 | PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE | Osyris | 2008-07-17 | Traditional | PDF ↗ |
| K080975 | FENCER 308 EXCIMER LASER SYSTEM | Kera Harvest/Laser Max Medical Technologies Corp | 2008-07-15 | Traditional | PDF ↗ |
| K073074 | KEY LASER III 1243 US WITH DETECT | Kavo America | 2008-07-10 | Special | PDF ↗ |
| K081015 | CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 | Biolitec, Inc. | 2008-07-08 | Traditional | PDF ↗ |
| K080496 | MOSAIC ECO2 LASER SYSTEM | Lutronic Corporation | 2008-07-07 | Traditional | PDF ↗ |
| K080915 | FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | 2008-07-01 | Traditional | PDF ↗ |
| K081219 | APOLLO MINI IPL SYSTEM | Sandstone Medical Technologies, LLC | 2008-06-30 | Traditional | PDF ↗ |
| K072182 | ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060 | Alma Lasers , Ltd. | 2008-06-27 | Traditional | PDF ↗ |
| K080959 | DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 | Dornier Medtech America, Inc. | 2008-06-27 | Traditional | PDF ↗ |
| K081612 | AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS | Aesculight, LLC | 2008-06-25 | Traditional | PDF ↗ |
| K080244 | PALOMAR LUX 1540 HANDPIECE | Palomar Medical Products, Inc. | 2008-06-20 | Traditional | PDF ↗ |
| K081578 | ACCELA SYSTEM | Genesis Biosystems, Inc. | 2008-06-20 | Traditional | PDF ↗ |
| K081628 | MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO | New Star Lasers, Inc. | 2008-06-20 | Special | PDF ↗ |
| K081324 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS | Candela Corp. | 2008-06-17 | Special | PDF ↗ |
| K081589 | WATERLASE, VERSION 3.0 | Biolase Technology, Inc. | 2008-06-13 | Special | PDF ↗ |
| K080932 | MOSAIC LASER SYSTEM | Lutronic Corporation | 2008-06-09 | Special | PDF ↗ |
| K081416 | PALOMAR ASPIRE LASER PLATFORM | Palomar Medical Products, Inc. | 2008-05-29 | Traditional | PDF ↗ |
| K072564 | ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM | Alma Lasers , Ltd. | 2008-05-23 | Traditional | PDF ↗ |
| K080374 | BIOSYAG MEDICAL SYSTEM | Bios S.R.L. | 2008-05-15 | Traditional | PDF ↗ |
| K081214 | STYLA MICROLASER AND STYLAORTHO | Zap Lasers, LLC | 2008-05-14 | Traditional | PDF ↗ |
| K073411 | LITEDUO | Light Instruments | 2008-05-13 | Traditional | PDF ↗ |
| K073477 | PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS | Photonova Ofsweden AB | 2008-05-09 | Traditional | PDF ↗ |
| K081181 | SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER | Cynosure, Inc. | 2008-05-05 | Traditional | PDF ↗ |
| K080118 | ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE | Zeltiq Aesthetics | 2008-05-02 | Traditional | PDF ↗ |
| K073404 | IFS LASER SYSTEM | Intra Lase Corp. | 2008-04-25 | Traditional | PDF ↗ |
| K073715 | ELIPO | Syneron Medical, Ltd. | 2008-04-23 | Traditional | PDF ↗ |
| K080248 | SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES | Lutronic Corporation | 2008-04-23 | Traditional | PDF ↗ |
| K072682 | 50W CERALAS D 1950NM DIODE LASER | Biolitec, Inc. | 2008-04-18 | Traditional | PDF ↗ |
| K080525 | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W | Cook Urological, Inc. | 2008-04-17 | Traditional | PDF ↗ |
| K080567 | PALOMAR ASPIRE LASER PLATFORM | Palomar Medical Products, Inc. | 2008-04-16 | Traditional | PDF ↗ |
| K080163 | COOLTOUCH MODELS LC215 AND COOLLIPO | New Star Lasers, Inc. | 2008-04-10 | Traditional | PDF ↗ |
| K073617 | PHARAON LIPO | Osyris | 2008-04-09 | Traditional | PDF ↗ |
| K080697 | SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER | Global USA Distribution, LLC | 2008-04-07 | Traditional | PDF ↗ |
| K080735 | CRYOMINI | Zimmer Elektromedizin GmbH | 2008-04-04 | Special | PDF ↗ |
| K073534 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS | Candela Corp. | 2008-04-03 | Traditional | PDF ↗ |
| K073583 | MODIFICATION TO PALOMAR LUX1540 HANDPIECE | Palomar Medical Products, Inc. | 2008-03-26 | Traditional | PDF ↗ |
| K080104 | VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542 | Vascular Solutions, Inc. | 2008-03-26 | Traditional | PDF ↗ |
| K080406 | IPULSE, MODEL I400 | Cyden Limited | 2008-03-10 | Special | PDF ↗ |
| K073659 | XTRAC ULTRA 2, MODEL AL10000 | Photo Medex, Inc. | 2008-03-05 | Traditional | PDF ↗ |
| K070355 | FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY | Fotona D.D. | 2008-03-04 | Traditional | PDF ↗ |
| K073549 | Q-PLUS T | Quanta System Spa | 2008-02-28 | Traditional | PDF ↗ |
| K080006 | AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE | Cynosure, Inc. | 2008-02-28 | Special | PDF ↗ |
| K073048 | PETERIO UNIVERSAL LASER SCANNING HANDPIECE | Scilex, Ltd. | 2008-02-28 | Traditional | PDF ↗ |
| K073063 | 15W CERALAS D 1470NM DIODE LASER | Biolitec, Inc. | 2008-02-27 | Traditional | PDF ↗ |
| K071896 | FOX 940, MODEL 940 | Valam, Inc. | 2008-02-22 | Traditional | PDF ↗ |
| K073322 | FOX 1-980, FOX Q-1064, FOX-Q-810 | A.R.C Laser GmbH | 2008-02-22 | Traditional | PDF ↗ |
| K073332 | V-RASER DIODE LASER SYSTEM | Hoya Conbio, Inc. | 2008-02-14 | Traditional | PDF ↗ |
| K071363 | WATERLASE AND WATERLASE MD | Biolase Technology, Inc. | 2008-02-12 | Traditional | PDF ↗ |
| K053527 | SPECTRA HAIR REMOVAL LASER | Spectragenics, Inc. | 2008-02-01 | Traditional | PDF ↗ |
| K080121 | CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER | Cynosure, Inc. | 2008-01-31 | Traditional | PDF ↗ |
| K071734 | WATERLASE MD DERM | Biolase Technology, Inc. | 2008-01-25 | Traditional | PDF ↗ |
| K072779 | CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 | Biolitec, Inc. | 2008-01-24 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.