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 27 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K900570 | SURGILASE YAG 100 IN ORTHOPEDIC SURGERY | Surgilase, Inc. | 1990-05-01 | Traditional | PDF ↗ |
| K900511 | I.C. MEDICAL ADJUSTABLE DIRECT COUPLER | I.C Medical, Inc. | 1990-05-01 | Traditional | PDF ↗ |
| K901211 | SURGILASE SL50 SURGICAL LASER SYSTEM | Surgilase, Inc. | 1990-04-26 | Traditional | PDF ↗ |
| K901227 | SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120 | Surgilase, Inc. | 1990-04-26 | Traditional | PDF ↗ |
| K900128 | CL-OPE CONTACT LASER SYSTEM | Lca, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K901021 | F300 SERIES CONTACT FIBER HANDPIECES | Hgm Medical Laser Systems, Inc. | 1990-04-13 | Traditional | PDF ↗ |
| K901541 | LASER LAPAROSCOPIC CHOLECYSTECTOMY | Surgical Laser Technologies, Inc. | 1990-04-13 | Traditional | PDF ↗ |
| K900345 | SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERY | Sharplan Lasers, Inc. | 1990-04-10 | Traditional | PDF ↗ |
| K895945 | KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE | Laserscope | 1990-04-09 | Traditional | PDF ↗ |
| K900253 | MODEL 20-CH CARBON DIOXIDE LASER W/ADD'L USES | Pfizer Laser Systems | 1990-04-05 | Traditional | PDF ↗ |
| K900346 | SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMY | Sharplan Lasers, Inc. | 1990-04-04 | Traditional | PDF ↗ |
| K895347 | MICRORUPTOR III SYSTEM, CW ND: YAG LASER COMPONENT | Lasag Medical Lasers | 1990-04-02 | Traditional | PDF ↗ |
| K900592 | SHARPLAN MODEL 1055 SEALED CO2 SURGICAL LASER | Sharplan Lasers, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K900166 | NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS | Nidek, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K900463 | LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS | Ximed Medical Systems | 1990-03-22 | Traditional | PDF ↗ |
| K900076 | SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATOR | Sharplan Lasers, Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K900165 | NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM | Nidek, Inc. | 1990-03-22 | Traditional | PDF ↗ |
| K900066 | FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER | Luxar Corp. | 1990-03-19 | Traditional | PDF ↗ |
| K900153 | SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEM | Sharplan Lasers, Inc. | 1990-03-19 | Traditional | PDF ↗ |
| K896939 | DISPOSABLE FIBER OPTIC DELIVERY SYSTEM FOR ND:YAG | Fiber Delivery Concepts, Inc. | 1990-03-08 | Traditional | PDF ↗ |
| K892912 | MODEL JM-1 CO2 LASER | L.A.S.E.R., Inc. | 1990-03-06 | Traditional | PDF ↗ |
| K900077 | SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM | Sharplan Lasers, Inc. | 1990-03-06 | Traditional | PDF ↗ |
| K895656 | ACCU-BEAM WAVEGUIDE | Tti Medical | 1990-02-22 | Traditional | PDF ↗ |
| K897157 | OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM | Trimedyne, Inc. | 1990-02-22 | Traditional | PDF ↗ |
| K896762 | SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY | Sharplan Lasers, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K897099 | MODEL 2800 ND:YAG OPHTHALMIC LASER | Alcon Surgical, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K897040 | LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (NEURO.) | Luxar Corp. | 1990-02-13 | Traditional | PDF ↗ |
| K896838 | BISTAT ELECTROSURGICAL UNIT 60-5400-001 | Aspen Laboratories, Inc. | 1990-02-13 | Traditional | PDF ↗ |
| K896517 | ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER | Heraeus Lasersonics, Inc. | 1990-02-09 | Traditional | PDF ↗ |
| K900144 | QUARTZ FIBER CATHETERS AND SURGICAL TIPS | Pfizer Laser Systems | 1990-02-09 | Traditional | PDF ↗ |
| K896478 | LUXAR MODEL LX-20 MINILASE CO2 LASER | Luxar Corp. | 1990-02-08 | Traditional | PDF ↗ |
| K896183 | KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY | Laserscope | 1990-02-02 | Traditional | PDF ↗ |
| K896412 | GAS MIXTURES AS DEVICE COMPONENTS | Spectra Gases, Inc. | 1990-02-01 | Traditional | PDF ↗ |
| K896847 | SHARPLAN 1030 SEALED CO2 SURGICAL LASER SYSTEM | Sharplan Lasers, Inc. | 1990-01-24 | Traditional | PDF ↗ |
| K896988 | NIIC LASER SYSTEM | Niic U.S.A., Inc. | 1990-01-23 | Traditional | PDF ↗ |
| K896049 | 35 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM | Pfizer Laser Systems | 1990-01-11 | Traditional | PDF ↗ |
| K896711 | LISTING PODIATRY AS INTENDED USE FOR ENDOGUIDE | Luxar Corp. | 1990-01-09 | Traditional | PDF ↗ |
| K896617 | LISTING ENT AS INTENDED USE FOR ENDOGUIDE | Luxar Corp. | 1990-01-09 | Traditional | PDF ↗ |
| K896618 | LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE | Luxar Corp. | 1990-01-09 | Traditional | PDF ↗ |
| K896619 | LIST DERMATOLOGY/PLASTIC SURGERY AS USE ENDOGUIDE | Luxar Corp. | 1990-01-09 | Traditional | PDF ↗ |
| K896595 | LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE | Luxar Corp. | 1990-01-09 | Traditional | PDF ↗ |
| K895774 | GYN-PROBE | Trimedyne, Inc. | 1990-01-03 | Traditional | PDF ↗ |
| K895874 | OPTILASE YAG MODEL 1000 | Trimedyne, Inc. | 1990-01-03 | Traditional | PDF ↗ |
| K895918 | STERILE DISPOSABLE INFRATIP | Heraeus Lasersonics, Inc. | 1989-12-14 | Traditional | PDF ↗ |
| K895837 | MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR | Medical Laser, Inc. | 1989-12-14 | Traditional | PDF ↗ |
| K895581 | MODEL: IR205 ARTICULATED SURGICAL LASER | Niic U.S.A., Inc. | 1989-12-13 | Traditional | PDF ↗ |
| K895663 | SITE 810E PHOTOCOAGULATOR AND ACCESSORIES | Site Microsurgical Systems, Inc. | 1989-12-04 | Traditional | PDF ↗ |
| K895518 | COHERENT HOLMIUM:YAG SURGICAL LASER | Lumenis, Inc. | 1989-11-30 | Traditional | PDF ↗ |
| K895430 | HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100 | Heraeus Lasersonics, Inc. | 1989-11-28 | Traditional | PDF ↗ |
| K892359 | MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM | Niic U.S.A., Inc. | 1989-11-16 | Traditional | PDF ↗ |
| K895247 | MODEL IR103 SURGICAL LASER SYSTEM | Niic U.S.A., Inc. | 1989-11-16 | Traditional | PDF ↗ |
| K895239 | MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER | Niic U.S.A., Inc. | 1989-11-16 | Traditional | PDF ↗ |
| K894471 | SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY | Surgilase, Inc. | 1989-11-14 | Traditional | PDF ↗ |
| K895279 | LASERMATIC COMBOLASER MODEL 5050 | Lasermatic OY | 1989-11-08 | Traditional | PDF ↗ |
| K895786 | ENDOGUIDE PRODUCT LINE: EX0120, EX0300 AND EX0400 | Luxar Corp. | 1989-10-27 | Traditional | PDF ↗ |
| K895299 | LASERMEDIC 1200 RUBY LASER SYSTEM | Lasermetrics, Inc. | 1989-10-24 | Traditional | PDF ↗ |
| K895348 | MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT | Lasag Medical Lasers | 1989-10-20 | Traditional | PDF ↗ |
| K895263 | ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS | Heraeus Lasersonics, Inc. | 1989-10-20 | Traditional | PDF ↗ |
| K895559 | MODIFIED ENDOGUIDE | Luxar Corp. | 1989-10-20 | Traditional | PDF ↗ |
| K895029 | SLT CONTACT LASER SYSTEMS FOR PHOTOCOAGULATION | Surgical Laser Technologies, Inc. | 1989-10-16 | Traditional | PDF ↗ |
| K895073 | POW-IR TIP | Living Technology, Inc. | 1989-10-10 | Traditional | PDF ↗ |
| K894977 | OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM | Trimedyne, Inc. | 1989-10-10 | Traditional | PDF ↗ |
| K894591 | GYNEGUIDE | Marlo Surgical Technology | 1989-10-10 | Traditional | PDF ↗ |
| K894841 | IRIS OCULIGHT(TM) SL | Iriderm Div. | 1989-10-05 | Traditional | PDF ↗ |
| K895746 | SHARPLAN MODEL 710 MICROSPOT | Sharplan Lasers, Inc. | 1989-10-05 | Traditional | PDF ↗ |
| K894709 | NIDEK MODEL ADC-8000 | Nidek, Inc. | 1989-10-04 | Traditional | PDF ↗ |
| K894962 | CO2 LASER BRONCHOSCOPE COUPLER | Cuda Products Co. | 1989-09-28 | Traditional | PDF ↗ |
| K895042 | SHARPLAN CO2 LASERS FOR ARTHROSCOPIC SURGERY | Sharplan Lasers, Inc. | 1989-09-27 | Traditional | PDF ↗ |
| K895143 | COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS | Lumenis, Inc. | 1989-09-25 | Traditional | PDF ↗ |
| K895093 | SLT CONTACT LASER SYSTEMS | Surgical Laser Technologies, Inc. | 1989-09-18 | Traditional | PDF ↗ |
| K894186 | SURGIFLEX LASER CONTACT TIPS | Cabot Medical Corp. | 1989-09-12 | Traditional | PDF ↗ |
| K894164 | MODELS 4000,4900,6000,8000,8900 ND YAG 1700ND | Heraeus Lasersonics, Inc. | 1989-08-29 | Traditional | PDF ↗ |
| K894074 | CO2 SURGICAL LASER SYSTEM | Niic U.S.A., Inc. | 1989-08-24 | Traditional | PDF ↗ |
| K894066 | SHARPLAN CO2 LAPAROSCOPIC PROBE MODEL 792 TO 792BX | Sharplan Lasers, Inc. | 1989-08-10 | Traditional | PDF ↗ |
| K894210 | SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS | Sharplan Lasers, Inc. | 1989-08-10 | Traditional | PDF ↗ |
| K894211 | SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS | Sharplan Lasers, Inc. | 1989-08-10 | Traditional | PDF ↗ |
| K893956 | EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM | Living Technology, Inc. | 1989-08-10 | Traditional | PDF ↗ |
| K893832 | CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER | Heraeus Lasersonics, Inc. | 1989-08-09 | Traditional | PDF ↗ |
| K894396 | SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER | Surgilase, Inc. | 1989-08-07 | Traditional | PDF ↗ |
| K894393 | OPMILAS CO2-L | Carl Zeiss, Inc. | 1989-07-27 | Traditional | PDF ↗ |
| K893642 | MODIFIED ENDOGUIDE | Luxar Corp. | 1989-07-14 | Traditional | PDF ↗ |
| K892933 | INFRALASE-LASERGUIDE DELIVERY SYSTEM | Ximed Medical Systems | 1989-06-22 | Traditional | PDF ↗ |
| K893701 | SLT CONTACT LASER SYSTEM | Surgical Laser Technologies, Inc. | 1989-06-21 | Traditional | PDF ↗ |
| K893206 | SHARPLAN 1075 CO2 LASER | Sharplan Lasers, Inc. | 1989-06-21 | Traditional | PDF ↗ |
| K892516 | CANDELA PLDL-1 PULSED DYE LASER | Candela Laser Corp. | 1989-06-15 | Traditional | PDF ↗ |
| K893529 | COMBOLASER MODEL 5050 | Lasermatic, Inc. | 1989-06-08 | Traditional | PDF ↗ |
| K885257 | EAGLE - NEODYUMIUM DOPED YTTRIUM ALUMINUM GARNET | Living Technology, Inc. | 1989-06-05 | Traditional | PDF ↗ |
| K885170 | LASERCOMP MODEL: 10 STAR 10 | Laser-West | 1989-06-05 | Traditional | PDF ↗ |
| K885060 | PEGASUS | Pfizer Laser Systems | 1989-06-02 | Traditional | PDF ↗ |
| K891909 | LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS | Lifestream Int'L, Inc. | 1989-05-26 | Traditional | PDF ↗ |
| K891130 | LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC | Lifestream Int'L, Inc. | 1989-05-23 | Traditional | PDF ↗ |
| K893013 | LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE | Luxar Medical Laser Instruments | 1989-05-23 | Traditional | PDF ↗ |
| K892211 | HERAEUS LASERSONIC INC. STERILE DISPOSABLE FIBERS | Heraeus Lasersonics, Inc. | 1989-05-19 | Traditional | PDF ↗ |
| K890922 | ACCU-BEAM YAG FIBER | Tti Medical | 1989-05-15 | Traditional | PDF ↗ |
| K892346 | SLT CONTACT LASER SYSTEMS (GYNECOLOGY) | Surgical Laser Technologies, Inc. | 1989-05-01 | Traditional | PDF ↗ |
| K892345 | SLT CONTACT LASER SYSTEMS (NEUROSURGERY) | Surgical Laser Technologies, Inc. | 1989-04-27 | Traditional | PDF ↗ |
| K890775 | INFRALASE - LASERGUIDE DELIVERY SYSTEM | Ximed Medical Systems | 1989-04-21 | Traditional | PDF ↗ |
| K890287 | SHARPLAN MODEL 1050 SEALED-OFF CO2 SURGICAL LASER | Sharplan Lasers, Inc. | 1989-04-12 | Traditional | PDF ↗ |
| K891461 | SURGILASE YAG 100 SURGICAL ND:YAG LASER/GEN SURG | Surgilase, Inc. | 1989-04-06 | Traditional | PDF ↗ |
| K890286 | SHARPLAN MODEL 750 REMOTE CONTROL UNIT (RCU) | Sharplan Lasers, Inc. | 1989-04-05 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.