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 24 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K925642 | ZEISS DIODE-PUMPED SOLID STATE LASER | Carl Zeiss, Inc. | 1993-09-13 | Traditional | PDF ↗ |
| K931101 | ECLIPSE 2100(TM) MODEL 32, MODIFICATION | Cardiogenes | 1993-08-25 | Traditional | PDF ↗ |
| K930793 | MULTILINE; DLY-1 | Derma-Lase Co. | 1993-08-19 | Traditional | PDF ↗ |
| K931499 | Q-11 OPHTHALMIC LASER | Hgm, Inc. | 1993-08-19 | Traditional | PDF ↗ |
| K930975 | DERMA-LASE DLA-1 LASER | Derma-Lase Co. | 1993-08-19 | Traditional | PDF ↗ |
| K920865 | SHARPLAN 2100,3000,SHARPLASER 65, 40 | Sharplan Lasers, Inc. | 1993-08-02 | Traditional | PDF ↗ |
| K930099 | LASER HANDPIECE SHROUD | I.C Medical, Inc. | 1993-07-28 | Traditional | PDF ↗ |
| K930098 | SPECULUM SMOKE EVACUATOR TUBING | I.C Medical, Inc. | 1993-07-28 | Traditional | PDF ↗ |
| K930981 | ACCULITE(TM) OTOPROBE | Coherent Medical Group | 1993-07-28 | Traditional | PDF ↗ |
| K926210 | ECLIPSE 3200 | Cardiogenes | 1993-07-28 | Traditional | PDF ↗ |
| K933017 | MODEL 5030 SUCTION HANDPIECE SYSTEM | Sunrise Technologies, Inc. | 1993-07-26 | Traditional | PDF ↗ |
| K931306 | ECLIPSE 3200 FOR USE IN ORTHO SURG/ARTH APPL JOINT | Cardiogenes | 1993-07-23 | Traditional | PDF ↗ |
| K931774 | UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER | Sunrise Technologies, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K926224 | DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS | Diomedics, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K932065 | DLASE 300 UPGRADE | Incirt Tech., Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K924213 | ECLIPSE 2100(TM), MODIFICATION | Elipse Surgical Technologies, Inc. | 1993-07-13 | Traditional | PDF ↗ |
| K924588 | ZEISS LASER INDIRECT OPHTHALMOSCOPE | Carl Zeiss, Inc. | 1993-07-09 | Traditional | PDF ↗ |
| K925908 | AP01 AND AP02 | Surgical Laser Technologies, Inc. | 1993-07-02 | Traditional | PDF ↗ |
| K925840 | ECLIPSE 3200 | Cardiogenes | 1993-06-25 | Traditional | PDF ↗ |
| K931051 | MODEL 110 ND:YAG LASER | Excel Tech. , Ltd. | 1993-06-25 | Traditional | PDF ↗ |
| K930543 | E-25 KRYPTON ION LASER (SURGICA K5) | Hgm, Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K924647 | DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST | Derma-Lase Co. | 1993-06-04 | Traditional | PDF ↗ |
| K930879 | 2.5 WATT PULSED DENTAL LASER SYSTEM | Sunrise Technologies, Inc. | 1993-05-21 | Traditional | PDF ↗ |
| K930789 | 8-WATT PULSED DENTAL LASER SYSTEM | Sunrise Technologies, Inc. | 1993-05-21 | Traditional | PDF ↗ |
| K924943 | ECLIPSE 3200(TM) HO:YAG LASER FOR PERCU DISKETOMY | Cardiogenes | 1993-05-17 | Traditional | PDF ↗ |
| K923599 | OPTILITE FIBEROPTIC DELIVERY SYSTEMS | Xintec Corporation | 1993-05-17 | Traditional | PDF ↗ |
| K924457 | MICROMANIPULATOR | Laser Engineering, Inc. | 1993-05-07 | Traditional | PDF ↗ |
| K930361 | ASI CYSTOLASE LASER CYSTOSCOPE | Advanced Surgical Intervention, Inc. | 1993-04-29 | Traditional | PDF ↗ |
| K930210 | ACL-5500 | Ilt Systems, Inc. | 1993-04-23 | Traditional | PDF ↗ |
| K924424 | UNIMEDIX HOLMIUM FIBER | Unimedix, Inc. | 1993-04-23 | Traditional | PDF ↗ |
| K924160 | HYBRID SURGICAL DEVICE | Lca, Inc. | 1993-04-23 | Traditional | PDF ↗ |
| K913566 | ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM | Alfred O. Bonati, M.D. | 1993-04-20 | Traditional | PDF ↗ |
| K924664 | SURGILASE FIBERLASE CO2 LASER WAVEGUIDE | Surgilase, Inc. | 1993-04-15 | Traditional | PDF ↗ |
| K922577 | CONBIO-MEDLITE(TM) Q-SWITCHED ND:YAG LASER SYSTEM | Continuum Biomedical, Inc. | 1993-04-07 | Traditional | PDF ↗ |
| K922935 | CONBIO-MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM | Buckman Co., Inc. | 1993-04-07 | Traditional | PDF ↗ |
| K924537 | LPI ML210 HOLMIUM SURGICAL LASER | Laser Photonics, Inc. | 1993-04-07 | Traditional | PDF ↗ |
| K930159 | OPTICON(TM) CONNECTOR ADAPTER | Xintec Corporation | 1993-04-07 | Traditional | PDF ↗ |
| K923274 | ZEISS VISULAS DIODE LASER | Carl Zeiss, Inc. | 1993-04-05 | Traditional | PDF ↗ |
| K923991 | ZOE LASER, CONTACT ND:YAG LASER SYSTEM | Lca, Inc. | 1993-03-31 | Traditional | PDF ↗ |
| K930490 | SLT MULTIDIMENSIONAL CONTACT LASER SYST A4060C | Surgical Laser Technologies, Inc. | 1993-03-31 | Traditional | PDF ↗ |
| K920334 | LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH. | Laser Photonics, Inc. | 1993-03-31 | Traditional | PDF ↗ |
| K923191 | SWITCHABLE TIP SYSTEM | Trimedyne, Inc. | 1993-03-31 | Traditional | PDF ↗ |
| K922213 | LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK | Trimedyne, Inc. | 1993-03-20 | Traditional | PDF ↗ |
| K924120 | MOLDED FIBER CAP DELIVERY SYSTEM | Lca, Inc. | 1993-03-19 | Traditional | PDF ↗ |
| K925549 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | Sunrise Technologies, Inc. | 1993-03-09 | Traditional | PDF ↗ |
| K910825 | ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC. | Pfizer Laser Systems | 1993-02-26 | Traditional | PDF ↗ |
| K924644 | ENDOSTATS, MICROSTATS, ACCUSTATS | Laserscope | 1993-02-23 | Traditional | PDF ↗ |
| K921549 | DORNIER FIBERTOME 100 WATT SURGICAL LASER | Dornier Medtech America, Inc. | 1993-02-18 | Traditional | PDF ↗ |
| K924166 | OPTILINK(TM) LPM (LASER POWER MODULATOR) | Xintec Corporation | 1993-02-05 | Traditional | PDF ↗ |
| K914520 | DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICAT | Dio-Med Corp. | 1993-01-22 | Traditional | PDF ↗ |
| K924158 | CANDELA LASSER SYSTEMS MODIFIED | Candela Laser Corp. | 1993-01-15 | Traditional | PDF ↗ |
| K914521 | DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT | Dio-Med Corp. | 1993-01-15 | Traditional | PDF ↗ |
| K924729 | EXCEL TRIPULSE MODEL3000 | Excel Tech. , Ltd. | 1993-01-15 | Traditional | PDF ↗ |
| K923855 | SHARPULSE | Sharplan Lasers, Inc. | 1992-12-24 | Traditional | PDF ↗ |
| K922807 | FIBERLIFE | Laser Surgical Systems | 1992-12-15 | Traditional | PDF ↗ |
| K923896 | HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS | Heraeus Lasersonics, Inc. | 1992-11-25 | Traditional | PDF ↗ |
| K922901 | INCISOR I PULSED ND:YAG LASER SYSTEM | Buckman Co., Inc. | 1992-11-20 | Traditional | PDF ↗ |
| K923953 | MEGABEAM | Ceram Optec, Inc. | 1992-11-17 | Traditional | PDF ↗ |
| K922881 | CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC | Clarus Medical Systems, Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K924214 | ECLIPSE 2100(TM) MODEL 32 | Cardiogenes | 1992-11-16 | Traditional | PDF ↗ |
| K914334 | ALCON(R) FX2(TM) PHOTOCOAGULATOR | Alcon Laboratories | 1992-11-13 | Traditional | PDF ↗ |
| K920708 | MULTILASE 2500 A | Teknomed, Inc. | 1992-11-05 | Traditional | PDF ↗ |
| K913917 | MULTILASE 2100 C, 2100 D | Teknomed, Inc. | 1992-11-05 | Traditional | PDF ↗ |
| K921990 | ASI UROPLASTY LASER CYSTOSCOPE | Advanced Surgical Intervention, Inc. | 1992-10-28 | Traditional | PDF ↗ |
| K923341 | ZEISS VISULAS ARGON LASER | Carl Zeiss, Inc. | 1992-10-28 | Traditional | PDF ↗ |
| K923539 | AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP | American Dental Laser, Inc. | 1992-10-28 | Traditional | PDF ↗ |
| K923683 | CYNOSURE PHOTOGENICA T TATTOO REMOVAL LASER | Cynosure, Inc. | 1992-10-15 | Traditional | PDF ↗ |
| K921300 | MODEL PC ARGON ION LASER | Hgm Medical Laser Systems, Inc. | 1992-10-06 | Traditional | PDF ↗ |
| K921708 | CYTOCARE LASER CATHETER FOR UROLOGY | Cytocare, Inc. | 1992-10-01 | Traditional | PDF ↗ |
| K922917 | ENDOPROBES | Endooptiks, Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K914678 | ODYSSEY HO:YAG SURGICAL LASER SYSTEM | Xintec Corporation | 1992-09-21 | Traditional | PDF ↗ |
| K913990 | KTP/532 & KTP/YAG | Laserscope | 1992-09-02 | Traditional | PDF ↗ |
| K921843 | CYNOSURE PHOTODENT, INTRAORAL SURGICAL LASER | Cynosure, Inc. | 1992-08-14 | Traditional | PDF ↗ |
| K920673 | PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT | Percudisc, Inc. | 1992-08-13 | Traditional | PDF ↗ |
| K922663 | IRIS OCULIGHT SL | Iriderm Div. | 1992-08-11 | Traditional | PDF ↗ |
| K921841 | CYNOSURE PHOTOGENICA P PIGMENTED LESION LASER | Cynosure, Inc. | 1992-08-04 | Traditional | PDF ↗ |
| K923050 | ND:YAG LASER-12 | Laser Endo Technic | 1992-08-03 | Traditional | PDF ↗ |
| K921096 | LASER-6 | Laser Endo Technic | 1992-07-28 | Traditional | PDF ↗ |
| K913244 | KTP/532 & KTP/YAG SURGICAL LASERS | Charles L. Rose and Co., Inc. | 1992-07-28 | Traditional | PDF ↗ |
| K914918 | LASERSCOPE'S MICROSPOT DERMASTAT | Laserscope | 1992-07-24 | Traditional | PDF ↗ |
| K914136 | COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE | Coherent Medical Group | 1992-07-21 | Traditional | PDF ↗ |
| K921840 | CYNOSURE PHOTOTRIPTER LASER | Cynosure, Inc. | 1992-07-16 | Traditional | PDF ↗ |
| K922634 | SLT LASER DELIVERY SYSTEM | Surgical Laser Technologies, Inc. | 1992-07-15 | Traditional | PDF ↗ |
| K920967 | ZEISS MULTI YAG LASER | Carl Zeiss, Inc. | 1992-07-08 | Traditional | PDF ↗ |
| K922375 | EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG | Excel Tech. , Ltd. | 1992-07-08 | Traditional | PDF ↗ |
| K921842 | CYNOSURE PHOTGENICA V CUTANEOUS VAS. LESION LASER | Cynosure, Inc. | 1992-07-08 | Traditional | PDF ↗ |
| K921320 | ELIOS DIODE OPHTHALMIC LASER | Marco Ophthalmic, Inc. | 1992-07-02 | Traditional | PDF ↗ |
| K921298 | MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER | Cj Laser Corp. | 1992-07-02 | Traditional | PDF ↗ |
| K921380 | LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER | Laserscope | 1992-06-25 | Traditional | PDF ↗ |
| K915679 | EXCEL DUOPAULSE MODEL 2000 | Excel Tech. , Ltd. | 1992-06-24 | Traditional | PDF ↗ |
| K921807 | ULTRALINE STERILE DISPOSABLE FIBER | Heraeus Lasersonics, Inc. | 1992-06-18 | Traditional | PDF ↗ |
| K921671 | SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE | Surgical Products Corp. | 1992-06-18 | Traditional | PDF ↗ |
| K912067 | POLARIS, GYNECOLOGY INDICATIONS | Pfizer Laser Systems | 1992-06-16 | Traditional | PDF ↗ |
| K915651 | OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM | Summit Technology, Inc. | 1992-06-15 | Traditional | PDF ↗ |
| K915631 | LPI ML 100/532 AND ML 532 SURGICAL LASER | Laser Photonics, Inc. | 1992-06-15 | Traditional | PDF ↗ |
| K915578 | ND;YAG SURGICAL LASER SYSTEMS | Heraeus Lasersonics, Inc. | 1992-06-15 | Traditional | PDF ↗ |
| K921146 | SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40 | Sharplan Lasers, Inc. | 1992-06-08 | Traditional | PDF ↗ |
| K920659 | DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES | Davol, Inc. | 1992-06-05 | Traditional | PDF ↗ |
| K920062 | CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS. | Candela Laser Corp. | 1992-06-05 | Traditional | PDF ↗ |
| K921038 | ECLIPSE 2100 | Cardiogenes | 1992-06-04 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.