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 18 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K002032 | C02 LASER MULTIPULSE | Asclepion-Meditec AG | 2000-09-11 | Traditional | PDF ↗ |
| K001704 | ATHOS | Cosmos Medical Technology | 2000-08-31 | Traditional | PDF ↗ |
| K000811 | NLITE SYSTEM, SLS MODEL NUMBER A00-1025 | Sls Biophile , Ltd. | 2000-08-25 | Traditional | PDF ↗ |
| K000158 | VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 | Fisma, Inc. | 2000-08-24 | Traditional | PDF ↗ |
| K001589 | CANDELA DYNAMIC COOLING DEVICE | Candela Corp. | 2000-08-18 | Traditional | PDF ↗ |
| K002347 | COOLTOUCH II | New Star Lasers, Inc. | 2000-08-17 | Special | PDF ↗ |
| K001975 | CERALAS D10 810NM LASER, MODEL CERALAS D10-60 | Ceram Optec, Inc. | 2000-08-04 | Traditional | PDF ↗ |
| K990119 | EPI-STAR SURGICAL LASER SYSTER | Nidek, Inc. | 2000-07-27 | Traditional | PDF ↗ |
| K001527 | FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES | Fotona D.D. | 2000-07-27 | Traditional | PDF ↗ |
| K001746 | LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS) | Coherent Star | 2000-07-19 | Traditional | PDF ↗ |
| K001511 | O-LAS OPHTHALMIC PHOTODISRUPTOR | A.R.C. Laser AG | 2000-07-19 | Traditional | PDF ↗ |
| K993328 | SURGILIGHT, INC EXCIMER LASER | Surgilight, Inc. | 2000-07-18 | Traditional | PDF ↗ |
| K001322 | PERFORMER 30 HPS | Cornelia Damsky, Inc. | 2000-06-30 | Traditional | PDF ↗ |
| K001031 | URANUS, COMFORTOUCH LASER SYSTEM | Laser Max Medical Technologies Corp. | 2000-06-29 | Traditional | PDF ↗ |
| K992757 | CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER | Cynosure, Inc. | 2000-06-29 | Traditional | PDF ↗ |
| K993154 | LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM | A.R.C. Laser Corp. | 2000-06-29 | Traditional | PDF ↗ |
| K000990 | OPUS 10 DENTAL DIODE LASER | Opusdent , Ltd. | 2000-06-23 | Traditional | PDF ↗ |
| K000072 | DORNIER MEDILAS D SKINPULSE | Dornier Surgical Products, Inc. | 2000-06-12 | Traditional | PDF ↗ |
| K994116 | LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) | Aesculap-Meditec North America | 2000-06-01 | Traditional | PDF ↗ |
| K994260 | CANDELA GENTLELASE GL DERMATOLOGICAL LASER | Candela Corp. | 2000-05-26 | Traditional | PDF ↗ |
| K001243 | DORNIER MEDILAS H | Dornier Surgical Products, Inc. | 2000-05-24 | Traditional | PDF ↗ |
| K994225 | PALOMAR SLP 2000 | Palomar Medical Technologies, Inc. | 2000-05-18 | Traditional | PDF ↗ |
| K000693 | UMECO OPTIMA MULTILINE LASER SYSTEM | Medical Laser Solutions, LLC | 2000-05-16 | Traditional | PDF ↗ |
| K000503 | MEDART 520 COOLING SYSTEM | Medart Corp. | 2000-05-15 | Traditional | PDF ↗ |
| K993815 | UNI-LASER 430 | Medart Corp. | 2000-05-11 | Traditional | PDF ↗ |
| K001263 | SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 | E S C Sharplan | 2000-05-05 | Special | PDF ↗ |
| K000805 | KAVO K.E.Y. LASER 1242 | Kavo America | 2000-05-04 | Traditional | PDF ↗ |
| K000982 | A100 AESTHETIC DIODE LASER | Diomed, Inc. | 2000-05-01 | Traditional | PDF ↗ |
| K992597 | LORAD LT-100 LASER TREATMENT SYSTEM | Focus Medical, LLC | 2000-04-24 | Traditional | PDF ↗ |
| K000222 | UM-L25 | Union Medical Engeneering Co., Ltd. | 2000-04-19 | Traditional | PDF ↗ |
| K000106 | DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES | Fotona D.D. | 2000-04-18 | Traditional | PDF ↗ |
| K000192 | E3 MICROPROB SERIES OF LASERS AND ACCESSORIES | Martin Uram, MD | 2000-04-10 | Traditional | PDF ↗ |
| K000498 | COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER | Lumenis, Inc. | 2000-03-13 | Special | PDF ↗ |
| K000490 | CYNOSURE PHOTOGENICA VLS-STAR | Cynosure, Inc. | 2000-03-13 | Special | PDF ↗ |
| K990718 | ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) | Laserscope | 2000-03-08 | Traditional | PDF ↗ |
| K991798 | ACME MEDICAL AESTHETIC ND:YAG LASER | Altus Medical | 2000-03-06 | Traditional | PDF ↗ |
| K994014 | ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT | Esc Medical Systems , Ltd. | 2000-02-24 | Traditional | PDF ↗ |
| K993834 | SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C | Cardiofocus, Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K993828 | CERALAS D10 810NM DIODE LASER | Ceram Optec, Inc. | 2000-02-01 | Traditional | PDF ↗ |
| K993911 | CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50 | Ceram Optec, Inc. | 2000-02-01 | Traditional | PDF ↗ |
| K992914 | EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000 | Acculase, Inc. | 2000-01-27 | Traditional | PDF ↗ |
| K991935 | EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM | Esc Medical Systems , Ltd. | 2000-01-27 | Traditional | PDF ↗ |
| K993671 | CANDELA SCLERO LONG PULSE DYE LASER | Candela Corp. | 2000-01-24 | Traditional | PDF ↗ |
| K994273 | MODEL 1000 HOLMIUM LASER SYSTEM | New Star Lasers, Inc. | 2000-01-20 | Traditional | PDF ↗ |
| K994427 | CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL | Cynosure, Inc. | 2000-01-18 | Special | PDF ↗ |
| K993942 | LITESABER 2000 | Laser Dental Innovations | 2000-01-18 | Traditional | PDF ↗ |
| K994437 | CYNOSURE PHOTOGENICA SPIR | Cynosure, Inc. | 2000-01-18 | Traditional | PDF ↗ |
| K992482 | DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) | Radiancy, Ltd. | 1999-12-27 | Traditional | PDF ↗ |
| K993209 | SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY | Thermolase Corp. | 1999-12-23 | Traditional | PDF ↗ |
| K993153 | INTRALASE 600C LASER KERATOME | Intra Lase Corp. | 1999-12-17 | Traditional | PDF ↗ |
| K994010 | INNOVAQUARTZ GENERAL SHAPE LASER FIBER | Innovaquartz | 1999-12-17 | Traditional | PDF ↗ |
| K992298 | IRIDERM, MODEL APEX 800 | Iridex Corp | 1999-12-09 | Traditional | PDF ↗ |
| K992866 | OPTILITE IX LASER SURGERY ACCESSORIES | Convergent Laser Technologies | 1999-11-18 | Traditional | PDF ↗ |
| K993285 | AURORA SL | Premier Laser Systems, Inc. | 1999-11-18 | Traditional | PDF ↗ |
| K991993 | PHACOLASE ER: YAG LASER | Aesculap-Meditec GmbH | 1999-11-17 | Traditional | PDF ↗ |
| K992824 | LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL | Ellex Medical Pty, Ltd. | 1999-11-17 | Traditional | PDF ↗ |
| K993146 | DORNIER SCANNER HANDPIECE | Dornier Surgical Products, Inc. | 1999-11-08 | Traditional | PDF ↗ |
| K992574 | OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A | Trimedyne, Inc. | 1999-10-29 | Traditional | PDF ↗ |
| K992707 | MCL 29 DERMABLATE ER:YAG LASER SYSTEM | Aesculap-Meditec North America | 1999-10-19 | Traditional | PDF ↗ |
| K993002 | CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 | Ceram Optec, Inc. | 1999-10-14 | Traditional | PDF ↗ |
| K992536 | TECHNOSANAT KRYO TSK 2005 | Technosanat Innovative Medizintechnik GmbH | 1999-10-08 | Traditional | PDF ↗ |
| K992374 | AURORA HL | Premier Laser Systems, Inc. | 1999-09-22 | Traditional | PDF ↗ |
| K992814 | CYNOSURE ACCOLADE LASER | Cynosure, Inc. | 1999-09-15 | Special | PDF ↗ |
| K992630 | THERMALIGHT 2000 | Jennifermaxx, Inc. | 1999-09-10 | Traditional | PDF ↗ |
| K991994 | TWILIGHT | Biolase Technology, Inc. | 1999-09-10 | Traditional | PDF ↗ |
| K992013 | DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER | Continuum Biomedical, Inc. | 1999-09-08 | Traditional | PDF ↗ |
| K992472 | SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM | Clinicon Corp. | 1999-09-08 | Traditional | PDF ↗ |
| K992765 | CYNOSURE DIODERM | Cynosure, Inc. | 1999-09-08 | Traditional | PDF ↗ |
| K992773 | CERALAS D10 810NM DIODE LASER | Ceram Optec, Inc. | 1999-09-01 | Traditional | PDF ↗ |
| K990903 | LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) | Laserscope | 1999-08-27 | Traditional | PDF ↗ |
| K992620 | BLULAZE | Premier Laser Systems, Inc. | 1999-08-20 | Traditional | PDF ↗ |
| K992508 | TSX PROBE, OCULAR CONTACT PROBE;TSX PROBE,OCULAR CONTACT PROBE,SMA | Instruments For Medicine and Diagnostics | 1999-08-19 | Traditional | PDF ↗ |
| K982860 | UM-L20/ UM-L30 | Union Medical Engeneering Co., Ltd. | 1999-08-13 | Traditional | PDF ↗ |
| K991634 | FOTONA NOVALIS R RUBY LASER SYSTEM | Fotona D.D. | 1999-08-10 | Traditional | PDF ↗ |
| K991632 | FOTONA NOVALIS ER: YAG LASER SYSTEM | Fotona D.D. | 1999-08-10 | Traditional | PDF ↗ |
| K991628 | MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA | Esc Medical Systems, Inc. | 1999-08-09 | Traditional | PDF ↗ |
| K992061 | PULSTAR | Lasermed, Inc. | 1999-07-30 | Traditional | PDF ↗ |
| K990914 | POLARIS DIODE LASER SYSTEM AND ACCESSORIES | Xintec Corporation | 1999-07-30 | Traditional | PDF ↗ |
| K990680 | DENTEC LD 15 DIODE LASER | Dentek Lasersystems Produktions Ges.M.B.H. | 1999-07-30 | Traditional | PDF ↗ |
| K991659 | UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES | Medart Corp. | 1999-07-29 | Traditional | PDF ↗ |
| K991464 | DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 | Fisma, Inc. | 1999-07-20 | Traditional | PDF ↗ |
| K992084 | CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER | Cynosure, Inc. | 1999-07-12 | Special | PDF ↗ |
| K992083 | SCATTERFREE LATERAL EMITTING FIBER | Laser Peripherals, LLC | 1999-07-12 | Special | PDF ↗ |
| K991285 | LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE | Aesculap-Meditec North America | 1999-07-12 | Traditional | PDF ↗ |
| K992230 | OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP | Trimedyne, Inc. | 1999-07-12 | Traditional | PDF ↗ |
| K991297 | UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES | Medart Corp. | 1999-07-12 | Traditional | PDF ↗ |
| K991234 | THE ACME MEDICAL AESTHETIC ND:YAG LASER | Acme Medical, Inc. | 1999-06-28 | Traditional | PDF ↗ |
| K991891 | CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15 | Ceram Optec, Inc. | 1999-06-24 | Traditional | PDF ↗ |
| K991183 | DORNIER LASERTRODE FIBER | Dornier Surgical Products, Inc. | 1999-06-09 | Traditional | PDF ↗ |
| K990243 | FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES | Fotona D.D. | 1999-06-09 | Traditional | PDF ↗ |
| K983984 | COOLTOUCH V ND:YAG | Laser Aesthetics, Inc. | 1999-06-07 | Traditional | PDF ↗ |
| K990902 | MODIFICATION OF MLT R694 RUBY LASER SYSTEM | Medical Laser Technologies , Ltd. | 1999-05-27 | Traditional | PDF ↗ |
| K990568 | SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01 | Synergetics, Inc. | 1999-05-14 | Traditional | PDF ↗ |
| K984486 | PULSEMASTER DENTAL LASER SYSTEM | American Dental Technologies, Inc. | 1999-05-13 | Traditional | PDF ↗ |
| K991258 | NOVUS VERDI DELIVERY SYSTEMS | Lumenis, Inc. | 1999-05-13 | Traditional | PDF ↗ |
| K990748 | EDGE SYSTEMS STERILE TUBING | Edge Systems Corp. | 1999-05-04 | Traditional | PDF ↗ |
| K990452 | ORLIGHT 2000 SURGICAL LASER SYSTEM | Ybeam Technologies, Inc. | 1999-04-29 | Traditional | PDF ↗ |
| K990947 | MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY | Lumenis, Inc. | 1999-04-27 | Traditional | PDF ↗ |
| K990417 | DERMACOOL | Optomed Corp. | 1999-04-14 | Traditional | PDF ↗ |
| K982940 | LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM | Star Medical Technologies, Inc. | 1999-04-08 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.