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 19 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K990174 | ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV | Fisma, Inc. | 1999-04-01 | Traditional | PDF ↗ |
| K983524 | LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP) | Lares Research, Inc. | 1999-04-01 | Traditional | PDF ↗ |
| K990851 | INDIGO LASEROPTIC TREATMENT SYSTEM | Indigo Medical, Inc. | 1999-03-30 | Traditional | PDF ↗ |
| K984591 | DORNIER MEDILAS H/2 | Dornier Surgical Products, Inc. | 1999-03-26 | Traditional | PDF ↗ |
| K990780 | NUVOLASE 532 CUTANEOUS LASER SYSTEM | American Laser Medical | 1999-03-22 | Special | PDF ↗ |
| K990725 | NUVOLASE 532 LASER SYSTEM | American Laser Corp. | 1999-03-22 | Special | PDF ↗ |
| K980840 | LOKKI DT | Hillard W. Welch | 1999-03-15 | Traditional | PDF ↗ |
| K984424 | AURA DYE LASER SYSTEM (ADLS) | Laserscope | 1999-03-05 | Traditional | PDF ↗ |
| K982980 | LIGHTSHEER LONG PULSE RUBY LASER | Palomar Medical Products, Inc. | 1999-03-04 | Traditional | PDF ↗ |
| K990014 | DIOSCAN | Diomed, Inc. | 1999-02-26 | Traditional | PDF ↗ |
| K984339 | MEDART 455 SCANNER SYSTEM | Del Mar Technologies, Inc. | 1999-02-18 | Traditional | PDF ↗ |
| K990043 | SMOOTHLASE ALEXANDRITE LASER SYSTEM | Leisegang Medical, Inc. | 1999-02-11 | Traditional | PDF ↗ |
| K983054 | MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER | Continuum Biomedical, Inc. | 1999-02-10 | Traditional | PDF ↗ |
| K984349 | DORNIER MEDILAS R | Dornier | 1999-02-04 | Traditional | PDF ↗ |
| K984601 | CANDELA GENTLELASE II DERMATOLOGICAL LASER | Candela Corp. | 1999-02-04 | Traditional | PDF ↗ |
| K982119 | DIODE LASER | Esc Medical Systems , Ltd. | 1999-02-04 | Traditional | PDF ↗ |
| K983950 | CERALAS DIODE LASER SYSTEM (MODEL H) | Ceram Optec, Inc. | 1999-02-03 | Traditional | PDF ↗ |
| K983868 | OPMI TWINER SURGICAL MICROSCOPE | Carl Zeiss, Inc. | 1999-01-29 | Traditional | PDF ↗ |
| K983100 | KAVO KEY LASER 1242 | Kavo America | 1999-01-27 | Traditional | PDF ↗ |
| K984517 | CYNOSURE ERASURE LASER | Cynosure, Inc. | 1999-01-20 | Special | PDF ↗ |
| K983673 | LASETTE | Cell Robotics, Inc. | 1999-01-15 | Traditional | PDF ↗ |
| K983654 | CYBER-LASE 2000 CURING AND WHITENING LASER | Ics of North America, Inc. | 1999-01-12 | Traditional | PDF ↗ |
| K983977 | LIGHT AGE EPICARE ALEXANDRITE LASER | Light Age, Inc. | 1999-01-07 | Traditional | PDF ↗ |
| K983965 | CO2 LASER COUPLER | L.A.S.E.R., Inc. | 1998-12-22 | Traditional | PDF ↗ |
| K984110 | LASERSCOPE COOLSPOT | Laserscope | 1998-12-18 | Traditional | PDF ↗ |
| K982316 | LASEAWAY ALEXANDRITE LASER SYSTEM | Silver Creek, Inc. | 1998-12-16 | Traditional | PDF ↗ |
| K980475 | UNIPULSE CO2 SURGICAL LASER SYSTEM | Nidek, Inc. | 1998-12-16 | Traditional | PDF ↗ |
| K983543 | ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM | Argus Photonics Group | 1998-12-16 | Traditional | PDF ↗ |
| K983463 | SURECAUT DIAMOND LASER KNIFE | Clinicon Corp. | 1998-12-11 | Traditional | PDF ↗ |
| K981746 | CELL ROBOTICS' LASETTE | Cell Robotics, Inc. | 1998-12-07 | Traditional | PDF ↗ |
| K983215 | MULTIPULSE CO2 LASER | Aesculap-Meditec GmbH | 1998-12-04 | Traditional | PDF ↗ |
| K983963 | DORNIER MEDILA H | Dornier Medtech America, Inc. | 1998-11-25 | Special | PDF ↗ |
| K983020 | COMPACT KTP LASER | Cosmos Medical Technology | 1998-11-25 | Traditional | PDF ↗ |
| K981379 | AURORA | Premier Laser Systems, Inc. | 1998-11-23 | Traditional | PDF ↗ |
| K983058 | CERALAS D LASER SYSTEM, MODEL # CERALAS D15 | Ceram Optec, Inc. | 1998-10-21 | Traditional | PDF ↗ |
| K982548 | MLT 30 LASER | Medical Laser Technologies , Ltd. | 1998-10-19 | Traditional | PDF ↗ |
| K983211 | CENTAURI | Premier Laser Systems, Inc. | 1998-10-09 | Traditional | PDF ↗ |
| K982113 | UMECO OPTIMA 694 RUBY LASER SYSTEM | Umeco, Inc. | 1998-09-30 | Traditional | PDF ↗ |
| K982230 | LASETTE LASER SKIN PERFORATOR | Cell Robotics, Inc. | 1998-09-24 | Traditional | PDF ↗ |
| K980398 | KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II | Optomedic Medical Technologies , Ltd. | 1998-09-22 | Traditional | PDF ↗ |
| K981143 | DILKES LASER/SUCTION CANNULAE | Exmoor Plastics , Ltd. | 1998-09-14 | Traditional | PDF ↗ |
| K982827 | DERMA K ER:YAG/CO2 LASER | Esc Medical Systems, Inc. | 1998-09-14 | Traditional | PDF ↗ |
| K982629 | DORNIER MEDILAS D | Dornier Surgical Products, Inc. | 1998-09-14 | Traditional | PDF ↗ |
| K983034 | CYNOSURE CO3 ER:YAG LASER | Cynosure, Inc. | 1998-09-10 | Special | PDF ↗ |
| K982031 | OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE | Iridex Corp | 1998-09-08 | Traditional | PDF ↗ |
| K981952 | COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER | Instruments For Medicine and Diagnostics | 1998-09-01 | Traditional | PDF ↗ |
| K980559 | PEGASUS ND:YAG LASER SYSTEM | Premier Laser Systems, Inc. | 1998-08-24 | Traditional | PDF ↗ |
| K982295 | NIDEK LIGHTSCAN | Nidek, Inc. | 1998-08-06 | Traditional | PDF ↗ |
| K981627 | PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) | Xintec Corporation | 1998-07-31 | Traditional | PDF ↗ |
| K980389 | MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES | Ceram Optec, Inc. | 1998-07-29 | Traditional | PDF ↗ |
| K980517 | EPILASER NORMAL MODE RUBY LASER | Palomar Medical Products, Inc. | 1998-07-21 | Traditional | PDF ↗ |
| K981438 | DORNIER MEDILAS E | Dornier Surgical Products, Inc. | 1998-07-20 | Traditional | PDF ↗ |
| K970069 | DUAL HOOK FIBEROPTIC DELIVERY SYSTEM | Ihd, Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K972575 | 800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES | Laserscope | 1998-07-17 | Traditional | PDF ↗ |
| K981718 | DORNIER MEDILAS H | Dornier Surgical Products, Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K974586 | AURORA DIODE LASER SYSTEM | Premier Laser Systems, Inc. | 1998-07-15 | Traditional | PDF ↗ |
| K981351 | CANDELA GENTLELASE GL DERMATOLOGICAL LASER | Candela Corp. | 1998-07-13 | Traditional | PDF ↗ |
| K981350 | ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES | Xintec Corporation | 1998-07-09 | Traditional | PDF ↗ |
| K980538 | LASER LANCET LB100 | Transmedica Intl., Inc. | 1998-07-09 | Traditional | PDF ↗ |
| K980501 | SKINTONER SYSTEM | Fuller Research Corp. | 1998-07-08 | Traditional | PDF ↗ |
| K981149 | LASETTE LASER SKIN PERFORATOR | Cell Robotics, Inc. | 1998-06-29 | Traditional | PDF ↗ |
| K980753 | CHROMOSCAN SCANNING SYSTEM | Mehl/Biophile Intl., Inc. | 1998-06-29 | Traditional | PDF ↗ |
| K981126 | CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3 | Ceram Optec, Inc. | 1998-06-25 | Traditional | PDF ↗ |
| K974641 | FUTURELASE 3000/3002 ERBIUM LASER SYSTEM | Buckman Co., Inc. | 1998-06-08 | Traditional | PDF ↗ |
| K981447 | DIO-LIGHT 60 LASER SYSTEM | Nidek, Inc. | 1998-06-05 | Traditional | PDF ↗ |
| K980838 | REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM | Ceram Optec, Inc. | 1998-06-02 | Traditional | PDF ↗ |
| K980710 | SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEM | Schwartz Electro-Optics, Inc. | 1998-05-22 | Traditional | PDF ↗ |
| K974536 | PHOTODERM HR SYSTEM | Esc Medical Systems , Ltd. | 1998-05-20 | Traditional | PDF ↗ |
| K980685 | MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS | Lumenis, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K980547 | NIDEK PRIMA MODEL GYC-1500/2000 | Nidek, Inc. | 1998-05-13 | Traditional | PDF ↗ |
| K971207 | SOFTLIGHT Q-SWITCHED (ND:YAG) LASER | Thermolase Corp. | 1998-05-13 | Traditional | PDF ↗ |
| K980420 | LIGHTSHEER | Palomar Medical Products, Inc. | 1998-05-04 | Traditional | PDF ↗ |
| K980784 | SURETOUCH | Sahar Technologies, Inc. | 1998-04-29 | Traditional | PDF ↗ |
| K974674 | CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM | Cynosure, Inc. | 1998-04-29 | Traditional | PDF ↗ |
| K980361 | DERMABLATE ER: YAG LASER SYSTEM | Aesculap-Meditec North America | 1998-04-21 | Traditional | PDF ↗ |
| K981090 | LASERLITE DIODE SURGICAL LASER | Laserlite, LLC | 1998-04-21 | Traditional | PDF ↗ |
| K974057 | DENTEK LD 15 LASERSYSTEM | Dentek Lasersystems Produktions Ges.M.B.H. | 1998-04-21 | Traditional | PDF ↗ |
| K972548 | SLT CL MD CONTACT LASER SYSTEM | Surgical Laser Technologies, Inc. | 1998-04-21 | Traditional | PDF ↗ |
| K980537 | ND: YAG ACCESSORY FOR PHOTODERM SYSTEM | Esc Medical Systems , Ltd. | 1998-04-15 | Traditional | PDF ↗ |
| K980187 | MLT R694 RUBY LASER SYSTEM | Medical Laser Technologies , Ltd. | 1998-04-03 | Traditional | PDF ↗ |
| K980142 | FEATHERLITE DIODE LASER | Laserlite, LLC | 1998-04-03 | Traditional | PDF ↗ |
| K980560 | FOTONA SKINPLUS LASER SYSTEM | Fotona D.D. | 1998-03-27 | Traditional | PDF ↗ |
| K974896 | LASERSCOPE EL LASER SYSTEM AND ACCESSORIES | Laserscope | 1998-03-27 | Traditional | PDF ↗ |
| K974878 | E3 MICROPROBE | Martin Uram, MD | 1998-03-27 | Traditional | PDF ↗ |
| K980313 | SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE | Schwartz Electro-Optics, Inc. | 1998-03-19 | Traditional | PDF ↗ |
| K980001 | JENASCAN | Jenoptik Laser, Optik, Systeme GmbH | 1998-03-19 | Traditional | PDF ↗ |
| K980561 | DERMIUM | Premier Laser Systems, Inc. | 1998-03-19 | Traditional | PDF ↗ |
| K974732 | NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000 | Nidek, Inc. | 1998-03-18 | Traditional | PDF ↗ |
| K980201 | DIO-LIGHT LASER SYSTEM | Nidek, Inc. | 1998-03-16 | Traditional | PDF ↗ |
| K980160 | EPILASER I UPGRADE KIT | Palomar Medical Products, Inc. | 1998-03-10 | Traditional | PDF ↗ |
| K974789 | COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L | Lumenis, Inc. | 1998-03-09 | Traditional | PDF ↗ |
| K980156 | SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS | Surgical Laser Technologies, Inc. | 1998-02-27 | Traditional | PDF ↗ |
| K974900 | CYNOSURE PHOTOGENICA 532 LASER | Cynosure, Inc. | 1998-02-27 | Traditional | PDF ↗ |
| K980131 | ALEX TA2 ERASER | Light Age, Inc. | 1998-02-17 | Traditional | PDF ↗ |
| K974381 | CANDELA GENTLELASE GL DERMATOLOGICAL LASER | Candela Corp. | 1998-02-10 | Traditional | PDF ↗ |
| K973867 | SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM | Schwartz Electro-Optics, Inc. | 1998-02-10 | Traditional | PDF ↗ |
| K974229 | LS-905 FIBERCHOICE ADAPTER SYSTEM | Laser Peripherals, LLC | 1998-02-10 | Traditional | PDF ↗ |
| K973172 | RESPOSABLE BARE FIBERS | Trimedyne, Inc. | 1998-02-03 | Traditional | PDF ↗ |
| K974142 | HM-RUBY | American Lasers, Inc. | 1998-01-28 | Traditional | PDF ↗ |
| K974460 | LITE TOUCH ERBIUM LASER TREATMENT SYSTEM | Lorad Corp. | 1998-01-16 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.