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 23 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K944091 | THE HOOK-CURVED CLOSED END/ELECT FIBER LASER DELIV SYS | Lca, Inc. | 1994-10-07 | Traditional | PDF ↗ |
| K944090 | CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER | Candela Laser Corp. | 1994-09-30 | Traditional | PDF ↗ |
| K943479 | GENEMED YAG 1000 MEDICAL LASER | Genemed, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K942934 | CONBIO CUB-D10 COOPER LASER SYSTEM | Continuum Biomedical, Inc. | 1994-09-27 | Traditional | PDF ↗ |
| K943171 | CROSSFIRE(TM) (705-10650) | Cardiogenes | 1994-09-20 | Traditional | PDF ↗ |
| K942786 | KARL STORZ LASER ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 1994-09-16 | Traditional | PDF ↗ |
| K920596 | FULL SPECTRUM ULE FIBER, MODEL FF101 | Gerald J. Shirk, M.D. | 1994-09-06 | Traditional | PDF ↗ |
| K934811 | PLTL-1 & PLDL-1 510NM PULSED DYE LASERS | Candela Laser Corp. | 1994-09-01 | Traditional | PDF ↗ |
| K942542 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | Sunrise Technologies, Inc. | 1994-09-01 | Traditional | PDF ↗ |
| K942759 | OPTICON(TM) CONNECTOR ADAPTER II | Xintec Corporation | 1994-08-31 | Traditional | PDF ↗ |
| K934501 | LASER PHOTONICS ML755 DERMABLASER | Laser Photonics, Inc. | 1994-08-30 | Traditional | PDF ↗ |
| K943445 | MEGABEAM FIBER OPTIC DELIVERY SYSTEM | Ceram Optec, Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K942204 | ARGON CURING LASER | Bio-Laser Technology, Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K943526 | MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYSTEM | Ceram Optec, Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K934208 | SLT PRISM/REFRACTING PROBE | Surgical Laser Technologies, Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K943444 | MEGABEAM LATERAL FIRE | Ceram Optec, Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K933918 | SHARPLAN MODEL 1080S CO2 SURGICAL LASER | Sharplan Lasers, Inc. | 1994-08-25 | Traditional | PDF ↗ |
| K942865 | LASER GAS MIXTURE | Nordan Smith Welding Supplies | 1994-08-23 | Traditional | PDF ↗ |
| K935631 | CONBIO MEDALEX LASER SYSTEM | Continuum Biomedical, Inc. | 1994-08-23 | Traditional | PDF ↗ |
| K943409 | SIDE-FIRING UROLOGIC REFRACTIVE FIBER | Energy Life Systems Corp. | 1994-08-23 | Traditional | PDF ↗ |
| K943693 | PULSEMASTER S SERIES | Incisive Technologies, Inc. | 1994-08-22 | Traditional | PDF ↗ |
| K941841 | SMARTSCAN | Laserscope | 1994-08-15 | Traditional | PDF ↗ |
| K943491 | RIGHT ANGLE UROLOGIC LASER FIBER | Surgitek | 1994-08-05 | Traditional | PDF ↗ |
| K942217 | PULSEJET DENTAL LASER SYSTEM | Incisive Technologies, Inc. | 1994-08-03 | Traditional | PDF ↗ |
| K915236 | IRIS G-PROBE | Iriderm Div. | 1994-07-28 | Traditional | PDF ↗ |
| K942152 | CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND;YAG LASER SY | Candela Laser Corp. | 1994-07-25 | Traditional | PDF ↗ |
| K943311 | ECLIPSE 3200 | Cardiogenes | 1994-07-22 | Traditional | PDF ↗ |
| K933318 | COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B | Lumenis, Inc. | 1994-07-08 | Traditional | PDF ↗ |
| K942343 | LASEAWAY Q-SWITCHED RUBY LASER SYSTEM | Polytec Pi, Inc. | 1994-07-08 | Traditional | PDF ↗ |
| K942182 | MEGABEAM DENTAL FIBER | Ceram Optec, Inc. | 1994-07-06 | Traditional | PDF ↗ |
| K942439 | ZEISS OPMILAS 144 SURGICAL LASERS | Zeiss Humphrey System | 1994-07-01 | Traditional | PDF ↗ |
| K941312 | SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN | Sharplan Lasers, Inc. | 1994-06-30 | Traditional | PDF ↗ |
| K941419 | DISPOSABLE SPINAL INTRODUCER SHEATH | Trimedyne, Inc. | 1994-06-21 | Traditional | PDF ↗ |
| K932883 | OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM | Trimedyne, Inc. | 1994-06-21 | Traditional | PDF ↗ |
| K940461 | ALEXANTRIPTOR | Servicetrends, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K940636 | CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM | Continuum Biomedical, Inc. | 1994-05-31 | Traditional | PDF ↗ |
| K940607 | CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM | Continuum Biomedical, Inc. | 1994-05-31 | Traditional | PDF ↗ |
| K941909 | MEGA BEAM LATERAL FIRE | Hogan & Hartson | 1994-05-23 | Traditional | PDF ↗ |
| K934211 | CYTOCARE DIODE LASER SYSTEM | Cytocare, Inc. | 1994-05-17 | Traditional | PDF ↗ |
| K936109 | SHARPLAN MODEL 1120 CO2 SURGICAL LASER | Sharplan Lasers, Inc. | 1994-05-17 | Traditional | PDF ↗ |
| K935563 | SHARPLAN SURGICAL CO2 LASERS AND ACCESSORIES | Sharplan Lasers, Inc. | 1994-05-17 | Traditional | PDF ↗ |
| K934865 | OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM | Trimedyne, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K941694 | ISL QC 2000 LASER | Intelligent Surgical Lasers, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K932981 | COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERS | Coherent Medical Group | 1994-05-02 | Traditional | PDF ↗ |
| K934706 | CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR | Candela Laser Corp. | 1994-04-29 | Traditional | PDF ↗ |
| K933245 | ULTRALINE II STERILE DISPOSABLE FIBER | Heraeus Lasersonics, Inc. | 1994-04-21 | Traditional | PDF ↗ |
| K933211 | D'AMICO\PEYMAN FLUTED ENDOPROBE | Iriderm Div. | 1994-04-19 | Traditional | PDF ↗ |
| K935495 | PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 | Perimed, Inc. | 1994-04-18 | Traditional | PDF ↗ |
| K934209 | SLT REFLECTING PROBE | Surgical Laser Technologies, Inc. | 1994-04-08 | Traditional | PDF ↗ |
| K933362 | SHARPLAN CO2 SURGICAL LASER | Laser Industries , Ltd. | 1994-04-07 | Traditional | PDF ↗ |
| K934486 | COOL LASER OPTICS (CLO) UNIT | Cyruschess | 1994-03-24 | Traditional | PDF ↗ |
| K935305 | CYNOSURE PHOTOTOME SURGICAL DIODE LASER | Cynosure, Inc. | 1994-03-18 | Traditional | PDF ↗ |
| K932062 | OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR | Alcon Laboratories | 1994-03-18 | Traditional | PDF ↗ |
| K931762 | CANDELA SPTL PULSED DYE LASERS | Candela Laser Corp. | 1994-03-15 | Traditional | PDF ↗ |
| K925178 | PEGASUS | Premier Laser Systems, Inc. | 1994-03-14 | Traditional | PDF ↗ |
| K924258 | MEGABEAM RADIAL EMIT SHAPE FIBER OPTIC DELIV SYST | Ceram Optec, Inc. | 1994-03-09 | Traditional | PDF ↗ |
| K926543 | SHARPLAN ND:YAG SURGICAL LASER, MODEL 3060 SHARPLASER 60 | Sharplan Lasers, Inc. | 1994-03-09 | Traditional | PDF ↗ |
| K933140 | RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEM | Laser Photonics, Inc. | 1994-03-02 | Traditional | PDF ↗ |
| K932730 | EXCEL'S EST-30 HO:YAG LASER SYSTEM | Excel Tech. , Ltd. | 1994-03-01 | Traditional | PDF ↗ |
| K933525 | DIOMED 25 25W SURGICAL DIODE LASER | Dio-Med Corp. | 1994-03-01 | Traditional | PDF ↗ |
| K925124 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST | Trimedyne, Inc. | 1994-03-01 | Traditional | PDF ↗ |
| K925414 | LATERALASE CATHETER | Trimedyne, Inc. | 1994-03-01 | Traditional | PDF ↗ |
| K922497 | OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM | Trimedyne, Inc. | 1994-03-01 | Traditional | PDF ↗ |
| K935775 | LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS | Heraeus Surgical, Inc. | 1994-03-01 | Traditional | PDF ↗ |
| K931264 | INFINITECH OTOPROBE | Infinitech, Inc. | 1994-03-01 | Traditional | PDF ↗ |
| K922496 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST | Trimedyne, Inc. | 1994-03-01 | Traditional | PDF ↗ |
| K933880 | SL SERIES SURGICAL LASER SYSTEMS | Laserscope | 1994-02-25 | Traditional | PDF ↗ |
| K923605 | MODIFIED SHARPLAN 1041 | Sharplan Lasers, Inc. | 1994-02-23 | Traditional | PDF ↗ |
| K933016 | CANDELA PLTL-1 LASER SYSTEM | Candela Laser Corp. | 1994-02-09 | Traditional | PDF ↗ |
| K932723 | CONBIO CUB-D10 COPPER LASER SYSTEM | Buckman Co., Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K934389 | UROTEK LASER CATHETER | Energy Life Systems Corp. | 1994-02-03 | Traditional | PDF ↗ |
| K934089 | BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S | Bio Quantum Technologies, Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K935258 | HYBRID SURGICAL DEVICE MODIFICATION | Lca, Inc. | 1994-01-13 | Traditional | PDF ↗ |
| K933007 | SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS | Sunrise Technologies, Inc. | 1994-01-10 | Traditional | PDF ↗ |
| K931305 | ECLIPSE 3200 FOR USE IN UROLOGY APPLICATIONS | Cardiogenes | 1994-01-07 | Traditional | PDF ↗ |
| K934008 | MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYST | Ceram Optec, Inc. | 1994-01-03 | Traditional | PDF ↗ |
| K935310 | MEDICAL LASER MIXTURE | Acetylene Gas Co. | 1993-12-23 | Traditional | PDF ↗ |
| K935034 | LASER GAS MIXTURE | Tri-Gas, Inc. | 1993-12-14 | Traditional | PDF ↗ |
| K932376 | ZEISS OPMILAS 144 SURGICAL LASERS | Carl Zeiss, Inc. | 1993-12-14 | Traditional | PDF ↗ |
| K930611 | TRUE FLOW(TM) VALVE | Gm Engineering, Inc. | 1993-12-01 | Traditional | PDF ↗ |
| K926452 | ZEISS VISULAS YAG II LASER | Carl Zeiss, Inc. | 1993-11-22 | Traditional | PDF ↗ |
| K933715 | BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE | Boston Scientific Corp | 1993-11-22 | Traditional | PDF ↗ |
| K934935 | ECLIPSE LAZERBLADE(TM) FIBEROPTIC DELIVERY SYSTEM | Cardiogenes | 1993-11-22 | Traditional | PDF ↗ |
| K925726 | ALLOY SCALPEL HANDPIECES, MODIFICATION | Lca, Inc. | 1993-11-22 | Traditional | PDF ↗ |
| K910826 | ORION YAG LASER SYSTEM OPHTHALMOLOGY | Pfizer Laser Systems | 1993-11-16 | Traditional | PDF ↗ |
| K911288 | ORION | Pfizer Laser Systems | 1993-11-16 | Traditional | PDF ↗ |
| K930582 | SHARPLAN SHARPLASE LATERAL ND:YAG FIBER | Sharplan Lasers, Inc. | 1993-11-02 | Traditional | PDF ↗ |
| K931776 | DIOMED 25 25W SURGICAL DIODE LASER | Dio-Med Corp. | 1993-10-19 | Traditional | PDF ↗ |
| K932156 | MULTILINE; DLY-1 | Derma-Lase Co. | 1993-10-15 | Traditional | PDF ↗ |
| K932421 | SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE | Surgilase, Inc. | 1993-10-15 | Traditional | PDF ↗ |
| K933322 | ZEISS OPMILAS 144 SURGICAL LASERS | Carl Zeiss, Inc. | 1993-10-15 | Traditional | PDF ↗ |
| K932272 | CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS | Lc Ent. | 1993-10-12 | Traditional | PDF ↗ |
| K924720 | VISIDISC KITS, SPINESCOPE | Laserscope | 1993-10-08 | Traditional | PDF ↗ |
| K931070 | CLOSED END FIBEROPTIC LASER DELIVERY SYSTEM | Lca, Inc. | 1993-10-05 | Traditional | PDF ↗ |
| K923575 | COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERS | Coherent Medical Group | 1993-09-29 | Traditional | PDF ↗ |
| K933333 | HGM SCANMAN PLUS | Hgm, Inc. | 1993-09-23 | Traditional | PDF ↗ |
| K931978 | SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM | Sharplan Lasers, Inc. | 1993-09-23 | Traditional | PDF ↗ |
| K931212 | DIOMED 25 25W SURGICAL DIODE LASER | Dio-Med Corp. | 1993-09-23 | Traditional | PDF ↗ |
| K932468 | NOVUS MULTIWAVELENGTH | Coherent Medical Group | 1993-09-22 | Traditional | PDF ↗ |
| K914519 | DIOMED 25 SURGICAL DIODE LASER, GYNECOLOGY APPLIC | Dio-Med Corp. | 1993-09-16 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.