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 16 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K030338 | ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002 | Curelight, Ltd. | 2003-02-12 | Special | PDF ↗ |
| K024064 | POLARIS DS | Syneron Medical, Ltd. | 2003-02-10 | Traditional | PDF ↗ |
| K022807 | MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA | Creative Technologies, Inc. | 2003-01-29 | Traditional | PDF ↗ |
| K023967 | PALOMAR Q-YAG ND:YAG LASER SYSTEM | Palomar Medical Technologies, Inc. | 2003-01-27 | Traditional | PDF ↗ |
| K023624 | SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 | Surgical Laser Technologies, Inc. | 2003-01-27 | Traditional | PDF ↗ |
| K022951 | CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG | Candela Corp. | 2003-01-27 | Traditional | PDF ↗ |
| K022341 | TERABYTE 2000 HAIR REMOVER | Terabyte Co. | 2003-01-27 | Traditional | PDF ↗ |
| K022884 | CANDELA SMOOTHBEAM LASER SYSTEM | Candela Corp. | 2003-01-22 | Traditional | PDF ↗ |
| K023464 | VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR | Quantel Medical | 2003-01-13 | Traditional | PDF ↗ |
| K021222 | LAD, MODEL LAD-01 | Norwood Abbey , Ltd. | 2003-01-08 | Traditional | PDF ↗ |
| K024088 | CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25 | Biolitec, Inc. | 2003-01-02 | Special | PDF ↗ |
| K022466 | PROFILE 1320 LASER SYSTEM | Sciton, Inc | 2002-12-31 | Traditional | PDF ↗ |
| K023962 | NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 | New Star Lasers, Inc. | 2002-12-24 | Special | PDF ↗ |
| K022607 | SPECTRAPULSE | Primary Technology, LLC | 2002-12-20 | Traditional | PDF ↗ |
| K023193 | CANDELA GENTLE YAG LASER SYSTEM | Candela Corp. | 2002-12-20 | Traditional | PDF ↗ |
| K023081 | PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION) | Medical Bio Care Sweden AB | 2002-12-16 | Traditional | PDF ↗ |
| K023041 | W.O.M. LASER U100 | W.O.M. World of Medicine AG | 2002-12-11 | Traditional | PDF ↗ |
| K021548 | FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM | Fotona D.D. | 2002-12-06 | Traditional | PDF ↗ |
| K023543 | EVLT KIT AND D15PLUS AND D30PLUS DIODE | Diomed, Inc. | 2002-12-02 | Traditional | PDF ↗ |
| K022838 | FOTONA DUALIS ER:YAG/KTP LASER SYSTEM | Fotona D.D. | 2002-11-25 | Traditional | PDF ↗ |
| K022837 | FOTONA TANDEM LASER SYSTEM | Fotona D.D. | 2002-11-25 | Traditional | PDF ↗ |
| K022839 | FOTONA DUALIS PLUS ND:YAG LASER SYSTEM | Fotona D.D. | 2002-11-25 | Traditional | PDF ↗ |
| K022817 | COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II | Icn Pharmaceuticals, Inc. | 2002-11-22 | Traditional | PDF ↗ |
| K022464 | EQUILASE SYSTEM | Equilasers, Inc. | 2002-11-21 | Traditional | PDF ↗ |
| K021444 | CYNOSURE PHOTOGENICA SV | Cynosure, Inc. | 2002-11-20 | Traditional | PDF ↗ |
| K022760 | MILLENNIUM MICROSURGICAL SYSTEM | Bausch & Lomb, Inc. | 2002-11-18 | Traditional | PDF ↗ |
| K022655 | TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH | Trimedyne, Inc. | 2002-11-07 | Traditional | PDF ↗ |
| K022610 | CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160 | Clarus Medical, LLC | 2002-11-05 | Traditional | PDF ↗ |
| K022583 | FLASH 1 | Emed, Inc. | 2002-10-31 | Traditional | PDF ↗ |
| K022060 | LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES | Lumenis, Inc. | 2002-10-30 | Traditional | PDF ↗ |
| K020339 | DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM | Dornier Medtech America, Inc. | 2002-10-25 | Traditional | PDF ↗ |
| K023182 | INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS | Ethicon Endo-Surgery, Inc. | 2002-10-24 | Special | PDF ↗ |
| K022381 | PROFILE 1320 LASER SYSTEM | Sciton, Inc | 2002-10-18 | Traditional | PDF ↗ |
| K022378 | PLASMALITE PULSED LIGHT SYSTEM | Medical Bio Care Sweden AB | 2002-10-18 | Traditional | PDF ↗ |
| K022327 | NOVUS SPECTRA | Lumenis, Inc. | 2002-10-16 | Traditional | PDF ↗ |
| K022338 | OPTICAL INTEGRITY GENERAL SHAPED FIBER | Optical Integrity, Inc. | 2002-10-16 | Traditional | PDF ↗ |
| K022351 | DIODENT DENTAL LASER SYSTEM | Continuum Electro-Optics, Inc. | 2002-10-16 | Traditional | PDF ↗ |
| K020839 | QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL | Lumenis, Inc. | 2002-10-11 | Traditional | PDF ↗ |
| K022228 | FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES | Iridex Corp | 2002-10-08 | Traditional | PDF ↗ |
| K022226 | ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS | Altus Medical, Inc. | 2002-10-08 | Traditional | PDF ↗ |
| K014128 | CANDELA SMOOTHBEAM LASER SYSTEM | Candela Corp. | 2002-10-04 | Traditional | PDF ↗ |
| K022266 | AURORA SR | Syneron Medical, Ltd. | 2002-10-03 | Traditional | PDF ↗ |
| K022181 | NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES | Lumenis, Inc. | 2002-10-01 | Traditional | PDF ↗ |
| K013974 | RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A | Trimedyne, Inc. | 2002-09-23 | Traditional | PDF ↗ |
| K021975 | LASERSYSTEM BEAUTYSTAR 532 | Asclepion-Meditec AG | 2002-09-13 | Traditional | PDF ↗ |
| K021946 | CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM | Cell Robotics, Inc. | 2002-09-11 | Traditional | PDF ↗ |
| K021848 | CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160 | Clarus Medical, LLC | 2002-09-03 | Traditional | PDF ↗ |
| K022569 | PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS | Medical Bio Care Sweden AB | 2002-08-29 | Special | PDF ↗ |
| K022568 | PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR | Medical Bio Care Sweden AB | 2002-08-29 | Special | PDF ↗ |
| K022544 | DORNIER MEDILAS H LASER FIBER CABLES | Dornier Medtech America, Inc. | 2002-08-21 | Special | PDF ↗ |
| K021696 | 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 | Ophthalmed, LLC | 2002-08-20 | Traditional | PDF ↗ |
| K021686 | LASER FIBER GF500 | W.O.M. World of Medicine AG | 2002-08-20 | Traditional | PDF ↗ |
| K021724 | DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS | Dornier Medtech America, Inc. | 2002-08-19 | Traditional | PDF ↗ |
| K021650 | ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER | Quantel Medical | 2002-08-16 | Traditional | PDF ↗ |
| K013623 | CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 | Curelight, Ltd. | 2002-08-16 | Traditional | PDF ↗ |
| K013691 | CERALAS D DIODE LASER SYSTEM, MODEL # D50 | Biolitec, Inc. | 2002-08-13 | Traditional | PDF ↗ |
| K021550 | LUMENIS SELECTA DUET | Ellex Medical Pty, Ltd. | 2002-08-09 | Traditional | PDF ↗ |
| K021508 | OPUSDUO EC DENTAL LASER SYSTEM | Opusdent , Ltd. | 2002-08-07 | Traditional | PDF ↗ |
| K021304 | PROLITE PULSED LIGHT SYSTEM | Big Sky Laser Technologies, Inc. | 2002-07-23 | Traditional | PDF ↗ |
| K021616 | DELIGHT DENTAL ER: YAG LASER SYSTEM | Continuum Electro-Optics, Inc. | 2002-07-11 | Traditional | PDF ↗ |
| K021149 | AURORA DS | Syneron Medical, Ltd. | 2002-07-09 | Traditional | PDF ↗ |
| K021180 | CANDELA VBEAM PULSED DYE LASER SYSTEM | Candela Corp. | 2002-07-02 | Traditional | PDF ↗ |
| K020021 | LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) | Laserscope | 2002-07-02 | Traditional | PDF ↗ |
| K021227 | SOFTLASE G2-SURGICAL DIODE LASER SYSTEM | Zap Lasers, LLC | 2002-06-26 | Traditional | PDF ↗ |
| K020958 | CANDELA CBEAM PULSED DYE LASER SYSTEM | Candela Corp. | 2002-06-21 | Traditional | PDF ↗ |
| K020941 | PALOMAR LUXG HANDPIECE | Palomar | 2002-06-19 | Traditional | PDF ↗ |
| K020856 | SPATOUCH PHOTOEPILATION SYSTEM | Radiancy (Israel) , Ltd. | 2002-06-13 | Traditional | PDF ↗ |
| K020835 | CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 | Biolitec, Inc. | 2002-06-12 | Traditional | PDF ↗ |
| K020729 | NLITE SYSTEM,MODEL A00-1051 | Icn Photonics , Ltd. | 2002-06-04 | Traditional | PDF ↗ |
| K014040 | FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS | Altus Medical, Inc. | 2002-06-03 | Traditional | PDF ↗ |
| K013021 | LIGHTLANCE LASER SKIN PERFORATOR | Innotech USA, Inc. | 2002-05-30 | Traditional | PDF ↗ |
| K020673 | WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER | Wave Form Mfg., Inc. | 2002-05-30 | Traditional | PDF ↗ |
| K020849 | APEX 800 LASER SYSTEM, MODEL APEX 800 | Iridex Corp | 2002-05-20 | Traditional | PDF ↗ |
| K020513 | EPY-50 | Ddc Technologies, Inc. | 2002-05-16 | Traditional | PDF ↗ |
| K020847 | XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 | Photo Medex, Inc. | 2002-05-16 | Traditional | PDF ↗ |
| K020453 | PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER | Palomar Medical Technologies, Inc. | 2002-05-10 | Traditional | PDF ↗ |
| K013300 | MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM | Technology Delivery Systems, Inc. | 2002-04-16 | Traditional | PDF ↗ |
| K020697 | DEPILASE TWIN YAG LASER SYSTEM | Depilase Group , Ltd. | 2002-04-12 | Abbreviated | PDF ↗ |
| K020099 | MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE | Biolitec, Inc. | 2002-04-11 | Traditional | PDF ↗ |
| K020072 | ATHOS LASER | Quantel Medical | 2002-04-09 | Traditional | PDF ↗ |
| K020071 | VIRIDIS DERMA LASER | Quantel Medical | 2002-04-05 | Traditional | PDF ↗ |
| K020973 | EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO | Surgilight, Inc. | 2002-03-29 | Traditional | PDF ↗ |
| K014272 | PERIOLASE ND:YAG DENTAL LASER SYSTEM | Millennium Dental Technologies, Inc. | 2002-03-27 | Traditional | PDF ↗ |
| K014236 | CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES | Clinicon Corp. | 2002-03-26 | Traditional | PDF ↗ |
| K014253 | DERMACHILLER 4 | Paradigm Trex, LLC | 2002-03-26 | Traditional | PDF ↗ |
| K013201 | CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR | Cardiofocus, Inc. | 2002-03-18 | Traditional | PDF ↗ |
| K014057 | DERMASTAR ER:YAG LASER SYSTEM | Asclepion-Meditec AG | 2002-03-08 | Traditional | PDF ↗ |
| K014035 | COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS | Cooltouch Corp. | 2002-03-07 | Traditional | PDF ↗ |
| K013216 | DIODENT DENTAL LASER SYSTEM | Continuum Electro-Optics, Inc. | 2002-02-27 | Traditional | PDF ↗ |
| K020463 | DEPILASE YAG LASE PLUS LASER SYSTEM | Depilase Group , Ltd. | 2002-02-27 | Traditional | PDF ↗ |
| K013941 | PULSION FS LASER KERATOME | Intra Lase Corp. | 2002-02-27 | Traditional | PDF ↗ |
| K013940 | LASER SYSTEM YELLOWSTAR | Asclepion-Meditec AG | 2002-02-26 | Traditional | PDF ↗ |
| K020412 | DEPILASE TWIN LASE LASER SYSTEM | Depilase Group , Ltd. | 2002-02-22 | Traditional | PDF ↗ |
| K013825 | CANDELA SMOOTHBEAM LASER SYSTEM | Candela Corp. | 2002-02-15 | Traditional | PDF ↗ |
| K014048 | CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS | Clinicon Corp. | 2002-02-11 | Traditional | PDF ↗ |
| K013748 | CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) | Candela Corp. | 2002-02-11 | Traditional | PDF ↗ |
| K013864 | MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 | Nidek, Inc. | 2002-02-08 | Traditional | PDF ↗ |
| K020107 | SMARTEPIL | Cynosure, Inc. | 2002-02-07 | Special | PDF ↗ |
| K012398 | DIOMED 15 DIODE LASER | Diomed, Ltd. | 2002-01-22 | Traditional | PDF ↗ |
| K014234 | MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER | Continuum Electro-Optics, Inc. | 2002-01-17 | Special | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.