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 21 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K963389 | FLEX-LASE 600 SERIES ION LASER SYSTEM | American Laser Medical | 1996-11-26 | Traditional | PDF ↗ |
| K963193 | ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 | Transamerican Technologies Intl. | 1996-11-13 | Traditional | PDF ↗ |
| K963124 | PC LASER WITH SMART PLUG (PC EDO & DENTAL 200) | Fisma, Inc. | 1996-11-08 | Traditional | PDF ↗ |
| K962068 | LIGHTSTIC MODEL 180 | Rare Earth Medical, Inc. | 1996-11-08 | Traditional | PDF ↗ |
| K963229 | SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS | Sharplan Lasers, Inc. | 1996-11-05 | Traditional | PDF ↗ |
| K961935 | SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER | Sharplan Lasers, Inc. | 1996-11-01 | Traditional | PDF ↗ |
| K961710 | AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM | Applied Optronics Corp. | 1996-11-01 | Traditional | PDF ↗ |
| K961705 | AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM | Applied Optronics Corp. | 1996-11-01 | Traditional | PDF ↗ |
| K962993 | CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS | Cynosure, Inc. | 1996-10-31 | Traditional | PDF ↗ |
| K962948 | CERALAS G ND;YAG LASER SYSTEM (CERALAS G) | Ceram Optec, Inc. | 1996-10-25 | Traditional | PDF ↗ |
| K962592 | OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS | Alcon Laboratories | 1996-09-23 | Traditional | PDF ↗ |
| K961006 | MEDLITE/755 ALEXANDRITE LASER SYSTEM | Continuum Biomedical, Inc. | 1996-09-11 | Traditional | PDF ↗ |
| K962354 | DIOMED 15, 30, 60 SURGICAL DIODE LASER | Lifestream Int'L, Inc. | 1996-09-11 | Traditional | PDF ↗ |
| K960772 | PHOTODERM PL. | Esc Medical Systems , Ltd. | 1996-09-11 | Traditional | PDF ↗ |
| K962242 | SURESCAN | Clinicon Corp. | 1996-09-03 | Traditional | PDF ↗ |
| K962974 | SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) | Sharplan Lasers, Inc. | 1996-08-21 | Traditional | PDF ↗ |
| K960636 | LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER | Heraeus Surgical, Inc. | 1996-08-21 | Traditional | PDF ↗ |
| K961682 | ARGON CURING LASER | Premier Laser Systems, Inc. | 1996-08-15 | Traditional | PDF ↗ |
| K961748 | MEDLITE/ERBIUM LASER SYSTEM | Continuum Biomedical, Inc. | 1996-07-26 | Traditional | PDF ↗ |
| K955612 | RD-1200H NORMAL MODE RUBY LASER SYSTEM | Spectrum Medical Technologies, Inc. | 1996-07-09 | Traditional | PDF ↗ |
| K961516 | LASER PERIPHERALS INC. BARE FIBER | Laser Peripherals, LLC | 1996-06-27 | Traditional | PDF ↗ |
| K961279 | SHARPLAN LASERS, INC. RUBY LASER SYSTEM | Sharplan Lasers, Inc. | 1996-06-18 | Traditional | PDF ↗ |
| K955662 | CANDELA Q-SWITCHED ALEXANDRITE LASERS | Candela Laser Corp. | 1996-06-14 | Traditional | PDF ↗ |
| K960905 | SDL DIODE LASER SYSTEM | Slt-J , Ltd. | 1996-06-03 | Traditional | PDF ↗ |
| K961136 | PULSEMASTER | American Dental Technologies, Inc. | 1996-06-03 | Traditional | PDF ↗ |
| K960086 | DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM | Slt-J , Ltd. | 1996-06-03 | Traditional | PDF ↗ |
| K961079 | LASER PERIPHERALS INC. SCATTERFREE FIBER | Laser Peripherals, LLC | 1996-05-22 | Traditional | PDF ↗ |
| K960821 | SLT FUMICH PROBE GUIDE | Surgical Laser Technologies, Inc. | 1996-05-16 | Traditional | PDF ↗ |
| K960768 | LASER FIBER DELIVERY/CLEANING CATHETER | Cook Urological, Inc. | 1996-05-14 | Traditional | PDF ↗ |
| K960867 | FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(EVERGREEN 532) | B.V. Intl. S.A. | 1996-05-14 | Traditional | PDF ↗ |
| K960820 | SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER | Sharplan Lasers, Inc. | 1996-05-10 | Traditional | PDF ↗ |
| K960475 | MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM | Luxar Corp. | 1996-04-26 | Traditional | PDF ↗ |
| K960521 | SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER | Sharplan Lasers, Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960579 | CYNOSURE PHOTOGENICA VL CUTANEOUS VASCULAR LESION LASER | Cynosure, Inc. | 1996-04-23 | Traditional | PDF ↗ |
| K960413 | COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT | Lumenis, Inc. | 1996-04-04 | Traditional | PDF ↗ |
| K960032 | COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS | Coherent Medical Group | 1996-04-01 | Traditional | PDF ↗ |
| K954905 | CB DIODE/532 LASER SYSTEM | Continuum Biomedical, Inc. | 1996-03-29 | Traditional | PDF ↗ |
| K951876 | PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIES | Xintec Corporation | 1996-03-25 | Traditional | PDF ↗ |
| K951935 | PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORIES | Xintec Corporation | 1996-03-25 | Traditional | PDF ↗ |
| K954597 | RIGHT ANGLE LASER FIBERS | Trimedyne, Inc. | 1996-03-11 | Traditional | PDF ↗ |
| K955862 | FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201 | Full Spectrum, Inc. | 1996-03-01 | Traditional | PDF ↗ |
| K955621 | SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNER | Sharplan Lasers, Inc. | 1996-02-27 | Traditional | PDF ↗ |
| K955131 | MEDLITE LASER SYSTEM | Continuum Biomedical, Inc. | 1996-02-20 | Traditional | PDF ↗ |
| K953851 | CERALAS F ND:YAG LASER SYSTEM | Ceram Optec, Inc. | 1996-02-16 | Traditional | PDF ↗ |
| K955758 | INDIGO MEDICAL MODEL IDL 830E | Indigo Medical, Inc. | 1996-02-16 | Traditional | PDF ↗ |
| K955734 | LASERSONICS PARASCAN DOSIMETER DEVICE | Heraeus Surgical, Inc. | 1996-02-13 | Traditional | PDF ↗ |
| K953585 | SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER | Schwartz Electro-Optics, Inc. | 1996-02-05 | Traditional | PDF ↗ |
| K954727 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION) | Surgical Laser Technologies, Inc. | 1996-02-05 | Traditional | PDF ↗ |
| K954934 | CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE | Candela Laser Corp. | 1996-02-02 | Traditional | PDF ↗ |
| K954013 | TRILASE 2940 ERBIUM LASER | Schwartz Electro-Optics, Inc. | 1996-01-31 | Traditional | PDF ↗ |
| K953670 | ACCUSCAN MODEL C CO2 LASER SCANNER | Reliant Technologies, Inc. | 1996-01-26 | Traditional | PDF ↗ |
| K955861 | MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER | Microquartz Medical, Inc. | 1996-01-26 | Traditional | PDF ↗ |
| K955007 | APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM | Applied Optronics Corp. | 1996-01-26 | Traditional | PDF ↗ |
| K955014 | APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE | Applied Optronics Corp. | 1996-01-26 | Traditional | PDF ↗ |
| K954195 | INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS | Indigo Medical, Inc. | 1996-01-25 | Traditional | PDF ↗ |
| K954911 | OMEGA ULTRASCAN | Gyne-Tech Instrument Corp. | 1996-01-24 | Traditional | PDF ↗ |
| K954904 | MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBER | Microquartz Medical, Inc. | 1996-01-22 | Traditional | PDF ↗ |
| K952489 | 6 WATT HOLMIUM LASER SYSTEM | New Star Lasers, Inc. | 1996-01-22 | Traditional | PDF ↗ |
| K954834 | CERALAS G FREQUENCY DOUBLED ND;YAG LASER SYSTEM | Ceram Optec, Inc. | 1996-01-17 | Traditional | PDF ↗ |
| K955006 | ECLIPSE 2100 | Cardiogenes | 1996-01-17 | Traditional | PDF ↗ |
| K951910 | ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES | Xintec Corporation | 1995-12-27 | Traditional | PDF ↗ |
| K954931 | NEO-MED DLS-1100 | Neo-Laboratories, LLC | 1995-12-18 | Traditional | PDF ↗ |
| K954460 | ILT SURGICAL LASER | Ion Laser Technology | 1995-12-18 | Traditional | PDF ↗ |
| K954316 | AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES | Premier Laser Systems, Inc. | 1995-12-15 | Traditional | PDF ↗ |
| K951760 | OPTILITE VIII LASER SURGERY ACCESSORIES | Xintec Corporation | 1995-11-29 | Traditional | PDF ↗ |
| K950826 | AM RUBY | American Lasers, Inc. | 1995-11-29 | Traditional | PDF ↗ |
| K953800 | MLT 20 | Medical Laser Technology, Inc. | 1995-11-29 | Traditional | PDF ↗ |
| K952277 | SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEM | Sharplan Lasers, Inc. | 1995-11-16 | Traditional | PDF ↗ |
| K953794 | SHARPLAN LASERS, INC. SURGICAL DIODE LASER | Sharplan Lasers, Inc. | 1995-11-14 | Traditional | PDF ↗ |
| K952682 | LOKKI DT | Lokki | 1995-11-14 | Traditional | PDF ↗ |
| K954544 | LASER GAS MIXTURE | Liquid Technology Corp. | 1995-10-30 | Traditional | PDF ↗ |
| K953917 | LASESONICS LOW POWER CO2 LASER SYSTEM | Heraeus Surgical, Inc. | 1995-10-26 | Traditional | PDF ↗ |
| K953412 | CANDELA MODEL PLTL-1 LASER SYSTEM | Candela Laser Corp. | 1995-10-24 | Traditional | PDF ↗ |
| K951117 | LIHTAN 532 LASER | Buckman Co., Inc. | 1995-10-18 | Traditional | PDF ↗ |
| K952661 | SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940 | Surgical Laser Technologies, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K950996 | DORNIER THERMAFOCUS 360 FIBER | Daimler-Benz Aerospace | 1995-10-03 | Traditional | PDF ↗ |
| K952047 | LMT 40 AA LASER SURGICAL SYSTEM | Laser Max Medical Technologies Corp. | 1995-10-03 | Traditional | PDF ↗ |
| K952045 | LMT 20 HH LASER SURGIVAL SYSTEM | Laser Max Medical Technologies Corp. | 1995-10-03 | Traditional | PDF ↗ |
| K952046 | LMT 20 AA LASER SURGICAL SYSTEM | Laser Max Medical Technologies Corp. | 1995-10-03 | Traditional | PDF ↗ |
| K953065 | ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER) | Microquartz Medical, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K952796 | ADVANCED LASER MULTILINE SYSTEM, ALY | Advanced Laser Services Corp. | 1995-09-18 | Traditional | PDF ↗ |
| K953494 | TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY | Trimedyne, Inc. | 1995-09-14 | Traditional | PDF ↗ |
| K952755 | POWERSCULPTOR PROBES | Cardiogenes | 1995-09-14 | Traditional | PDF ↗ |
| K953933 | MED-TECH LASER GAS MIXTURE | Medical Technical Gases Inc.. | 1995-09-01 | Traditional | PDF ↗ |
| K952974 | QUADRALASE (MICROQUARTZ MEDICAL ADJUSTABLE SIDE-FIRING LASER FIBER) | Microquartz Medical, Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K953074 | MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM | Luxar Corp. | 1995-08-28 | Traditional | PDF ↗ |
| K952554 | SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM | Schwartz Electro-Optics, Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K950825 | AM-YAG | American Lasers, Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K953174 | MICROQUATZ MEDICAL LINEAR MODULATOR ACCESSORY | Microquartz Medical, Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K953658 | CORSSFIRE PLUS | Cardiogenes | 1995-08-21 | Traditional | PDF ↗ |
| K952216 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM & WCE DIFFUSER FLAT PROBE DF 2 | Surgical Laser Technologies, Inc. | 1995-08-18 | Traditional | PDF ↗ |
| K950684 | CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER | Cynosure, Inc. | 1995-08-16 | Traditional | PDF ↗ |
| K953424 | ECLIPSE 3200 | Cardiogenes | 1995-08-11 | Traditional | PDF ↗ |
| K950120 | SMART PLUG | Hgm, Inc. | 1995-08-11 | Traditional | PDF ↗ |
| K952118 | ELMER | Biological Technology Corp. | 1995-08-07 | Traditional | PDF ↗ |
| K950493 | PHOTODERM VL. | Esc, Energy Systems Corp. | 1995-08-07 | Traditional | PDF ↗ |
| K952754 | SACS, INDEPENDENT FIBER COOLANT SYSTEM | Surgical Laser Technologies, Inc. | 1995-07-31 | Traditional | PDF ↗ |
| K952636 | MEDLITE LASER SYSTEM | Continuum Biomedical, Inc. | 1995-07-31 | Traditional | PDF ↗ |
| K952733 | SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS | Myriad Lase, Inc. | 1995-07-31 | Traditional | PDF ↗ |
| K951562 | OMNIPULSE-MAX HOLMIUM LASER | Trimedyne, Inc. | 1995-07-21 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.