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 22 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K952049 | TRU-PULSE PULSED CO2 SURGICAL LASER SYSTEM | Tissue Technologies, Inc. | 1995-07-21 | Traditional | PDF ↗ |
| K952813 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM | Surgical Laser Technologies, Inc. | 1995-07-20 | Traditional | PDF ↗ |
| K952772 | MEGABEAM ENDO-ENT PROBE | Ceram Optec, Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K952299 | SURGISCAN SCANNER | Norcross Scientific | 1995-07-17 | Traditional | PDF ↗ |
| K951775 | CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50) | Ceram Optec, Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K951714 | CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER | Cabot Medical Corp. | 1995-07-11 | Traditional | PDF ↗ |
| K951812 | MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS | Lumenis, Inc. | 1995-07-07 | Traditional | PDF ↗ |
| K952598 | GX-PAN PANORAMIC DENTAL X-RAY SYSTEM | Gendex Corp. | 1995-06-29 | Traditional | PDF ↗ |
| K950215 | ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE | Reliant Laser Corp. | 1995-06-15 | Traditional | PDF ↗ |
| K952340 | MEGABEAM ASPIRATING ENDOCULAR PROBE | Ceram Optec, Inc. | 1995-06-12 | Traditional | PDF ↗ |
| K951165 | SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEM | Sharplan Lasers, Inc. | 1995-06-12 | Traditional | PDF ↗ |
| K952301 | LASER GAS MIXTURE | Airgas Management, Inc. | 1995-06-01 | Traditional | PDF ↗ |
| K945564 | MODEL 550-DC CROSSFIRE(TM) | Eclipse, Inc. | 1995-06-01 | Traditional | PDF ↗ |
| K951204 | SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATOR | Sharplan Lasers, Inc. | 1995-06-01 | Traditional | PDF ↗ |
| K952113 | TBN-TIPPED OPTICAL FIBER | Myriad Lase, Inc. | 1995-06-01 | Traditional | PDF ↗ |
| K952162 | MEDICAL MIXTURE-LASER GAS MIXTURES | Standard Welders Supply Co. | 1995-06-01 | Traditional | PDF ↗ |
| K952006 | ACCU-BEAM FIBER OPTIC HANDPIECE | Tti Medical | 1995-05-31 | Traditional | PDF ↗ |
| K951933 | UROTEK RE-USABLE FIBEROPTIC CABLE | Energy Life Systems Corp. | 1995-05-26 | Traditional | PDF ↗ |
| K950831 | ALEXLAZR | Candela Laser Corp. | 1995-05-26 | Traditional | PDF ↗ |
| K945614 | ADD POWER FAMILY , MICRO ADDSTAT | Laserscope | 1995-05-15 | Traditional | PDF ↗ |
| K931490 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM FAMILY | Surgical Laser Technologies, Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K944558 | ELLMAN VAPOR-VAC II | North American Technical Services Corp. | 1995-04-28 | Traditional | PDF ↗ |
| K943411 | ACCUCURE 3000 | Lasermed | 1995-04-25 | Traditional | PDF ↗ |
| K950819 | SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER) | Surgical Laser Technologies, Inc. | 1995-04-18 | Traditional | PDF ↗ |
| K951215 | LASERSONICS ULTRALINE III STERILE DISPOSABLE FIBER | Heraeus Surgical, Inc. | 1995-04-18 | Traditional | PDF ↗ |
| K951034 | AURA LASER SYSTEM | Laserscope | 1995-04-13 | Traditional | PDF ↗ |
| K950725 | SHARPLAN MODEL 1015 CO2 LASER | Sharplan Lasers, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K950019 | THERMOLASE LT-100 ND:YAG LASER HAIR REMOVAL SYSTEM; THERMOLASE LT-100;LT-100 | Thermolase Corp. | 1995-04-03 | Traditional | PDF ↗ |
| K951045 | LASER GAS MIXTURE | Liquid Carbonic Industrial Gases | 1995-03-31 | Traditional | PDF ↗ |
| K946386 | CANDELA RUBY LAZE Q-SWITCHED RUBY LASER | Candela Laser Corp. | 1995-03-24 | Traditional | PDF ↗ |
| K950351 | CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) | Ion Laser Technology | 1995-03-24 | Traditional | PDF ↗ |
| K942622 | LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM | Mdi, Inc. | 1995-03-24 | Traditional | PDF ↗ |
| K950313 | KAPLAN PENDULASER 115 - A 15W CO2 SURGICAL LASER | Optomedic Medical Technologies , Ltd. | 1995-03-24 | Traditional | PDF ↗ |
| K945228 | 125MM HANDPIECE | Plc Medical Systems, Inc. | 1995-03-20 | Traditional | PDF ↗ |
| K946304 | COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES | Lumenis, Inc. | 1995-03-15 | Traditional | PDF ↗ |
| K943716 | LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES | Heraeus Surgical, Inc. | 1995-03-14 | Traditional | PDF ↗ |
| K944437 | DISPOSABLE LASER SWEEP TIP | Reliant Technologies, Inc. | 1995-03-14 | Traditional | PDF ↗ |
| K950710 | MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER | Microquartz Medical, Inc. | 1995-03-10 | Traditional | PDF ↗ |
| K950662 | DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT | Laserscope | 1995-03-10 | Traditional | PDF ↗ |
| K950661 | CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE | Candela Laser Corp. | 1995-03-10 | Traditional | PDF ↗ |
| K943292 | CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS | Candela Laser Corp. | 1995-03-09 | Traditional | PDF ↗ |
| K945156 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | New Star Lasers, Inc. | 1995-03-09 | Traditional | PDF ↗ |
| K943638 | USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM | United States Dental Laser, Inc. | 1995-03-06 | Traditional | PDF ↗ |
| K943201 | CLEAN AIR | Wallach Surgical Devices, Inc. | 1995-02-28 | Traditional | PDF ↗ |
| K945648 | ACCU-BEAM C02 LASER HANDPIECE | Tti Medical | 1995-02-24 | Traditional | PDF ↗ |
| K950248 | LASERSPRAY(TM) | Biolase Technology, Inc. | 1995-02-24 | Traditional | PDF ↗ |
| K950505 | 50MM HANDPIECE | Plc Medical Systems, Inc. | 1995-02-24 | Traditional | PDF ↗ |
| K945178 | TOUCH FOCUS 200MM DEFOCUSING HANDPIECE | Plc Medical Systems, Inc. | 1995-02-24 | Traditional | PDF ↗ |
| K946336 | MEGABEAM FIBER OPTIC DELIVERY SYSTEM | Hogan & Hartson | 1995-02-10 | Traditional | PDF ↗ |
| K931286 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM | Surgical Laser Technologies, Inc. | 1995-02-06 | Traditional | PDF ↗ |
| K944928 | PY30, PY60, PY80 | Huttinger Medizintechnik GmbH & CO KG | 1995-01-27 | Traditional | PDF ↗ |
| K945888 | MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEM | Luxar Corp. | 1995-01-27 | Traditional | PDF ↗ |
| K945181 | GENERA 100 SURGICAL SYSTEM | Xintec Corporation | 1995-01-20 | Traditional | PDF ↗ |
| K945560 | UROTEK LASER CATHETER | Energy Life Systems Corp. | 1995-01-18 | Traditional | PDF ↗ |
| K945126 | ECLIPSE 3200 | Cardiogenes | 1995-01-18 | Traditional | PDF ↗ |
| K944704 | OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES | Xintec Corporation | 1995-01-06 | Traditional | PDF ↗ |
| K944965 | OPTILITE VI FIBEROPTIC ACCESSORIES | Xintec Corporation | 1995-01-06 | Traditional | PDF ↗ |
| K946002 | ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA | Origin Medsystems, Inc. | 1995-01-05 | Traditional | PDF ↗ |
| K944758 | SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT | Cardiogenes | 1994-12-27 | Traditional | PDF ↗ |
| K944749 | OPTICA 100 SUPERPULSED LASER SYSTEM | Xintec Corporation | 1994-12-22 | Traditional | PDF ↗ |
| K942935 | ACUTOME 100 COLOR-CORRECTED CO2 LASER HANDPIECE | Reliant Technologies, Inc. | 1994-12-19 | Traditional | PDF ↗ |
| K941838 | MULTIPLE CO2 LAERS | Mattioli Engineering, Srl | 1994-12-15 | Traditional | PDF ↗ |
| K945563 | CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM)) | Energy Life Systems Corp. | 1994-12-15 | Traditional | PDF ↗ |
| K944474 | OPTILITE V FIBEROPTIC ACCESSORIES | Xintec Corporation | 1994-12-15 | Traditional | PDF ↗ |
| K942729 | LIHTAN 4100 KRYPTON | Lihtan Technologies, Inc. | 1994-12-13 | Traditional | PDF ↗ |
| K943045 | UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED | Reliant Technologies, Inc. | 1994-12-13 | Traditional | PDF ↗ |
| K945587 | CANDELA ELLIPTICAL SPOT HANDPIECE | Candela Laser Corp. | 1994-12-08 | Traditional | PDF ↗ |
| K940173 | CANDELA Q-SWITCHED ALEXANDRITE LASER | Candela Laser Corp. | 1994-12-07 | Traditional | PDF ↗ |
| K943527 | MEGABEAM LATERAL FIRE | Ceram Optec, Inc. | 1994-12-05 | Traditional | PDF ↗ |
| K931445 | KTP/532, KTP/YAG AND KTP/YAG XP | Laser Surgical Systems | 1994-12-02 | Traditional | PDF ↗ |
| K943543 | MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS | Medical Options, Inc. | 1994-12-02 | Traditional | PDF ↗ |
| K945054 | ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM | Cytocare, Inc. | 1994-11-28 | Traditional | PDF ↗ |
| K944204 | LATERALASE, MODIFIED | Trimedyne, Inc. | 1994-11-28 | Traditional | PDF ↗ |
| K942868 | ACUTOME 2000 COLOR-CORRECTED LAPAROSCOPIC C02 LASER COUPLER AND SLEEVES | Reliant Laser Corp. | 1994-11-14 | Traditional | PDF ↗ |
| K944630 | MODEL 230-SAS LASER DELIVERY PROBE | Mnlase, Inc. | 1994-11-09 | Traditional | PDF ↗ |
| K944153 | ECLIPSE 3200 | Cardiogenes | 1994-11-09 | Traditional | PDF ↗ |
| K944977 | COAXIAL ENDOSTAT | Laserscope | 1994-11-08 | Traditional | PDF ↗ |
| K944346 | LASERSONICS RADIANCE DIODE LASER SYSTEMS AND ACCESSORIES | Heraeus Surgical, Inc. | 1994-11-08 | Traditional | PDF ↗ |
| K921995 | CANDELA H:ERB LASER | Candela Laser Corp. | 1994-11-07 | Traditional | PDF ↗ |
| K944627 | MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-03 | Traditional | PDF ↗ |
| K944625 | MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-03 | Traditional | PDF ↗ |
| K944628 | MODEL 220-SS LASER DELIVERY PROBE | Mnlase, Inc. | 1994-11-03 | Traditional | PDF ↗ |
| K944629 | MODEL 230-SAC LASER DELIVERY PROBE | Mnlase, Inc. | 1994-11-03 | Traditional | PDF ↗ |
| K944471 | STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE | Mnlase, Inc. | 1994-11-03 | Traditional | PDF ↗ |
| K944470 | CURVED ENDOPHOTOCOAGULATOR LASER PROBE | Mnlase, Inc. | 1994-11-03 | Traditional | PDF ↗ |
| K944626 | MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-03 | Traditional | PDF ↗ |
| K941559 | PARADERM -585M DERMATOLOGICAL LASER | Paradigm Lasers, Inc. | 1994-11-03 | Traditional | PDF ↗ |
| K944624 | MODEL 130-SAC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K944622 | MODEL 110-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K944472 | CURVD ENDOPHOTOCOGULATOR LASER PROBE | Mnlase, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K945143 | DENTAL LASER FIBER SYSTEM | Incisive Technologies, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K933057 | MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM | Continuum Electro-Optics, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K944151 | OPTICAL FIBER FOR ENT APPLICATIONS | Cardiogenes | 1994-11-01 | Traditional | PDF ↗ |
| K944631 | MODEL 120-SC LASER DELIVERY PROBE | Mnlase, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K944623 | MODEL 130-SAS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K944621 | MODEL 110-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K944282 | LASER DELIVERY PROBE | Mnlase, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K944632 | MODEL 120-SS LASER DELIVERY PROBE | Mnlase, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K944317 | GENESIS 2000 | Ion Laser Technology | 1994-10-11 | Traditional | PDF ↗ |
| K944206 | GENESIS 2000 | Ion Laser Technology | 1994-10-11 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.