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 17 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K013461 | NLITE SYSTEM,MODEL A00-1025 | Icn Photonics , Ltd. | 2002-01-17 | Traditional | PDF ↗ |
| K013366 | PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR | Medical Bio Care Sweden AB | 2002-01-08 | Traditional | PDF ↗ |
| K013365 | PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS | Medical Bio Care Sweden AB | 2002-01-08 | Traditional | PDF ↗ |
| K014100 | OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND | Opusdent , Ltd. | 2002-01-08 | Special | PDF ↗ |
| K014130 | NLITE SYSTEM | Icn Photonics , Ltd. | 2002-01-08 | Special | PDF ↗ |
| K011939 | FOTONA DUALIS, FOTONA DUALIS PLUS | Fotona D.D. | 2001-12-27 | Traditional | PDF ↗ |
| K013193 | MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE | Biolitec, Inc. | 2001-12-21 | Traditional | PDF ↗ |
| K011960 | LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4) | Lares Research, Inc. | 2001-12-21 | Traditional | PDF ↗ |
| K013901 | MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) | Cardiofocus, Inc. | 2001-12-20 | Special | PDF ↗ |
| K013493 | INDIGO OPTIMA LASER SYSTEM | Ethicon Endo-Surgery, Inc. | 2001-12-13 | Traditional | PDF ↗ |
| K013028 | PALOMAR SLP 1000 | Palomar Medical Products, Inc. | 2001-12-06 | Traditional | PDF ↗ |
| K013047 | FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM | Mojca Valijavec | 2001-12-06 | Traditional | PDF ↗ |
| K012071 | ENT LASERVISION | Union Medical USA | 2001-12-03 | Traditional | PDF ↗ |
| K010771 | PERIOLASE ND:YAG DENTAL LASER SYSTEM | Millennium Dental Technologies, Inc. | 2001-11-27 | Traditional | PDF ↗ |
| K012806 | CYNOSURE PHOTOGENICA VL | Cynosure, Inc. | 2001-11-19 | Traditional | PDF ↗ |
| K011322 | DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE | Dornier Medtech America, Inc. | 2001-11-19 | Traditional | PDF ↗ |
| K013499 | DIOMED 15 PLUS AND DIOMED 30PLUS LASERS | Diomed, Inc. | 2001-11-16 | Special | PDF ↗ |
| K012790 | CYNOSURE PHOTOGENICA ER | Cynosure, Inc. | 2001-11-16 | Traditional | PDF ↗ |
| K013402 | VISULAS 532S | Carl Zeiss, Inc. | 2001-11-14 | Special | PDF ↗ |
| K012682 | REPROCESSED LASER PROBE | Sterilmed, Inc. | 2001-11-08 | Traditional | PDF ↗ |
| K011174 | PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES | Fotona D.D. | 2001-11-07 | Traditional | PDF ↗ |
| K011070 | DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR | Moor Instruments, Ltd. | 2001-11-07 | Traditional | PDF ↗ |
| K012552 | SCITON IMAGE HAIR REMOVAL LASER | Sciton, Inc | 2001-11-05 | Traditional | PDF ↗ |
| K012545 | ARAMIS DERMATLOGIC LASER | Lumedics, Ltd. | 2001-11-05 | Traditional | PDF ↗ |
| K011175 | W.O.M. LASER U100 | W.O.M. World of Medicine GmbH | 2001-11-01 | Traditional | PDF ↗ |
| K013043 | CANDELA CLEARBEAM PULSED DYE LASER | Candela Corp. | 2001-10-11 | Traditional | PDF ↗ |
| K011021 | LASER 20 | Ya-Man, Ltd. | 2001-10-09 | Traditional | PDF ↗ |
| K010715 | AL-40 | Ddc Technologies, Inc. | 2001-10-04 | Traditional | PDF ↗ |
| K012127 | PULSEMASTER ERBIUM DENTAL LASER SYSTEM | American Dental Technologies, Inc. | 2001-10-04 | Traditional | PDF ↗ |
| K010804 | MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS | Biolitec, Inc. | 2001-10-04 | Traditional | PDF ↗ |
| K012982 | COOLTOUCH VARIZOOM | New Star Lasers, Inc. | 2001-10-02 | Special | PDF ↗ |
| K010618 | PALOMAR DERMALUX PULSED LIGHT SYSTEM | Palomar | 2001-09-10 | Traditional | PDF ↗ |
| K011828 | CYNOSURE ACCLAIM DERMATOLOGY LASER | Cynosure, Inc. | 2001-09-07 | Traditional | PDF ↗ |
| K011769 | OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND | Opusdent , Ltd. | 2001-08-30 | Traditional | PDF ↗ |
| K011747 | PALOMAR LC 100 DIODE LASER | Palomar Medical Technologies, Inc. | 2001-08-30 | Traditional | PDF ↗ |
| K011703 | LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES | Lumenis | 2001-08-29 | Traditional | PDF ↗ |
| K002890 | INTRALASE 600C LASER KERATOME | Intra Lase Corp. | 2001-08-09 | Traditional | PDF ↗ |
| K011423 | INPULSE DENTAL LASER | Incisive, LLC | 2001-08-07 | Traditional | PDF ↗ |
| K011382 | XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000 | Photo Medex, Inc. | 2001-08-02 | Traditional | PDF ↗ |
| K011207 | LASER PERIPHERALS REUSABLE HOLMIUM FIBER | Laser Peripherals, LLC | 2001-07-24 | Traditional | PDF ↗ |
| K011092 | CANDELA SPTL-1E PULSED DYE LASER | Candela Corp. | 2001-07-09 | Traditional | PDF ↗ |
| K011041 | WATERLASE, MILLENNIUM | Biolase Technology, Inc. | 2001-07-03 | Traditional | PDF ↗ |
| K011677 | MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER | Continuum Electro-Optics, Inc. | 2001-06-22 | Special | PDF ↗ |
| K010928 | PROLITE VL PULSED LIGHT SYSTEM | Medical Bio Care Sweden AB | 2001-06-19 | Traditional | PDF ↗ |
| K010927 | MODIFICATION TO PROLITE PULSED LIGHT SYSTEM | Medical Bio Care Sweden AB | 2001-06-19 | Traditional | PDF ↗ |
| K011409 | SLT LASERPRO CTH HOLMIUM LASER SYSTEM | Surgical Laser Technologies, Inc. | 2001-06-14 | Traditional | PDF ↗ |
| K010885 | UNI-LASER 470 | Medart Corp. | 2001-06-07 | Traditional | PDF ↗ |
| K010580 | PALOMAR SLP 1000 | Palomar Medical Technologies, Inc. | 2001-05-22 | Traditional | PDF ↗ |
| K003318 | PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X | Paradigm Medical Industries, Inc. | 2001-05-22 | Traditional | PDF ↗ |
| K010834 | LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES | Laserscope | 2001-05-21 | Traditional | PDF ↗ |
| K010689 | MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM | Biolitec, Inc. | 2001-05-18 | Traditional | PDF ↗ |
| K010316 | COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM | Cooltouch Corp. | 2001-05-01 | Traditional | PDF ↗ |
| K010284 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | Laserscope | 2001-05-01 | Traditional | PDF ↗ |
| K003440 | SOFTLASE - SURGICAL DIODE LASER SYSTEM | Zap Lasers, Inc. | 2001-04-20 | Traditional | PDF ↗ |
| K010113 | LASER MECHANISMS LASER SCANNING SYSTEM | Laser Mechanisms, Inc. | 2001-04-12 | Traditional | PDF ↗ |
| K010104 | CANDELA LONG PULSE ND:YAG | Candela Corp. | 2001-04-11 | Traditional | PDF ↗ |
| K010046 | NUVOLASE 532 MEDICAL LASER SYSTEM | American Laser Corp. | 2001-04-05 | Traditional | PDF ↗ |
| K010005 | CYNOSURE PHOTOGENICA DL | Cynosure, Inc. | 2001-04-02 | Traditional | PDF ↗ |
| K004039 | CYNOSURE PHOTOGENICA NEO-V | Cynosure, Inc. | 2001-03-29 | Traditional | PDF ↗ |
| K004021 | F1 DIODE LASER SYSTEM | Opus Medical, Inc. | 2001-03-27 | Traditional | PDF ↗ |
| K004006 | SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER | Lumenis, Inc. | 2001-03-26 | Traditional | PDF ↗ |
| K003993 | DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) | Dornier Surgical Products, Inc. | 2001-03-26 | Traditional | PDF ↗ |
| K003953 | INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001 | Ethicon Endo-Surgery, Inc. | 2001-03-16 | Traditional | PDF ↗ |
| K003952 | INDIGO LASEROPTIC TREATMENT SYSTEM | Ethicon Endo-Surgery, Inc. | 2001-03-16 | Traditional | PDF ↗ |
| K004014 | MD 30 COMPACT | General Project | 2001-03-16 | Traditional | PDF ↗ |
| K003955 | LASEREX INTEGRE, MODEL LP2532 | Ellex Medical Pty, Ltd. | 2001-03-15 | Traditional | PDF ↗ |
| K003614 | LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM | Coherent Star | 2001-03-13 | Traditional | PDF ↗ |
| K010041 | SLT DIFFUSER FIBER | Surgical Laser Technologies, Inc. | 2001-03-07 | Traditional | PDF ↗ |
| K003765 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | Laserscope | 2001-03-06 | Traditional | PDF ↗ |
| K003715 | COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II | Cooltouch Corp. | 2001-03-01 | Traditional | PDF ↗ |
| K003886 | PALOMAR SPALIGHT PULSED LIGHT SYSTEM | Palomar Medical Technologies, Inc. | 2001-03-01 | Traditional | PDF ↗ |
| K010285 | CONTOUR PROFILE LASER | Sciton, Inc | 2001-03-01 | Special | PDF ↗ |
| K003705 | XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 | Photo Medex, Inc. | 2001-03-01 | Traditional | PDF ↗ |
| K003885 | VISULAS YAG II | Carl Zeiss, Inc. | 2001-02-22 | Traditional | PDF ↗ |
| K003541 | DENLASER, MODEL 800 | CAO Group, Inc. | 2001-01-25 | Traditional | PDF ↗ |
| K003460 | PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM | Palomar Medical Technologies, Inc. | 2001-01-25 | Traditional | PDF ↗ |
| K003385 | TWILITE, TWILITE WHITE | Biolase Technology, Inc. | 2001-01-25 | Traditional | PDF ↗ |
| K003202 | FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II | Altus Medical | 2001-01-10 | Traditional | PDF ↗ |
| K003151 | MICROPOBE SERIES OF LASERS AND ACCESSORIES | Endooptiks, Inc. | 2001-01-08 | Traditional | PDF ↗ |
| K002308 | OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A | Trimedyne, Inc. | 2000-12-20 | Traditional | PDF ↗ |
| K003781 | COOLTOUCH VARIA-II ND:YAG LASER SYSTEM | Cooltouch Corp. | 2000-12-20 | Special | PDF ↗ |
| K003147 | LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) | Laserscope | 2000-12-15 | Traditional | PDF ↗ |
| K002899 | OPUS 20, MODEL 1ST | Opusdent , Ltd. | 2000-12-12 | Traditional | PDF ↗ |
| K002853 | SCITON IMAGE HAIR REMOVAL LASER | Sciton, Inc | 2000-12-04 | Traditional | PDF ↗ |
| K002884 | PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES | Fotona D.D. | 2000-12-04 | Traditional | PDF ↗ |
| K001211 | MODIFICATION TO INTRALASE 600C LASER KERATOME | Intra Lase Corp. | 2000-12-04 | Traditional | PDF ↗ |
| K003046 | IMAGE VASCULAR LASER | Sciton, Inc | 2000-11-24 | Traditional | PDF ↗ |
| K002649 | ARAMIS DERMATOLOGICAL LASER | Palomar Medical Technologies, Inc. | 2000-11-21 | Traditional | PDF ↗ |
| K000023 | FRIENDLY LIGHT ER:YAG PULSED LASER | Innotech USA, Inc. | 2000-11-06 | Traditional | PDF ↗ |
| K002421 | CANDELA MID IR DIODE LASER SYSTEM | Candela Corp. | 2000-11-03 | Traditional | PDF ↗ |
| K001676 | OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A | Trimedyne, Inc. | 2000-11-02 | Traditional | PDF ↗ |
| K000317 | SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM | Tissue Medical Lasers, Inc. | 2000-10-27 | Traditional | PDF ↗ |
| K001990 | DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES | Depilase Group , Ltd. | 2000-10-23 | Traditional | PDF ↗ |
| K000929 | PROLITE PULSED LIGHT SYSTEM | Medical Bio Care Sweden AB | 2000-10-17 | Traditional | PDF ↗ |
| K002228 | PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X | Paradigm Medical Industries, Inc. | 2000-10-06 | Traditional | PDF ↗ |
| K002296 | CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 | Ceram Optec, Inc. | 2000-10-02 | Traditional | PDF ↗ |
| K001093 | CANDELA SPTL-1B PULSED DYE LASER | Candela Corp. | 2000-09-19 | Traditional | PDF ↗ |
| K000727 | BUFFLIGHT CLT SURGICAL LASER SYSTEM | Y-Beam Technologies, Inc. | 2000-09-19 | Traditional | PDF ↗ |
| K001784 | VIRIDIS LASER | Cosmos Medical Technology | 2000-09-11 | Traditional | PDF ↗ |
| K002072 | PROLITE VL PULSED LIGHT SYSTEM | Medical Bio Care Sweden AB | 2000-09-11 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.