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 26 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K910898 | SURGICA(TM) H | Hgm Medical Laser Systems, Inc. | 1991-05-31 | Traditional | PDF ↗ |
| K910200 | LASER-35 | Endo Technic Corp. | 1991-05-09 | Traditional | PDF ↗ |
| K910496 | CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. | Heraeus Lasersonics, Inc. | 1991-05-06 | Traditional | PDF ↗ |
| K910894 | HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS | Heraeus Lasersonics, Inc. | 1991-04-22 | Traditional | PDF ↗ |
| K911523 | MODIFICATION TO MODEL 90-1460 LASER ADAPTER | Lifestream Int'L, Inc. | 1991-04-22 | Traditional | PDF ↗ |
| K905676 | MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH | Laser Engineering, Inc. | 1991-04-22 | Traditional | PDF ↗ |
| K904841 | LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED | Laser Photonics, Inc. | 1991-04-19 | Traditional | PDF ↗ |
| K904068 | LUXAR MODEL LX-20 CO2 LASER | Luxar Corp. | 1991-04-15 | Traditional | PDF ↗ |
| K910233 | LASER PHOTONICS ML-210 HOLMIUM:YAG MEDI LASE SYST | Laser Photonics, Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K910114 | OPTILITE (TM) FIBEROPTIC DELIVERY SYSTEMS AND ACCE | Xintec Corporation | 1991-04-09 | Traditional | PDF ↗ |
| K904420 | DISPOSABLE FIBER OPTIC DELIVERY SYSTEM | Fiber Delivery Concepts, Inc. | 1991-04-08 | Traditional | PDF ↗ |
| K910137 | PLP LAPAROSCOPIC CHOLECYSTECTOMY SET | Precision Laser Products, Inc. | 1991-04-08 | Traditional | PDF ↗ |
| K910051 | SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 65 | Sharplan Lasers, Inc. | 1991-04-08 | Traditional | PDF ↗ |
| K910726 | LIGHT-TOUCH AND SURGI LIGHT FIBERS | Lifestream Int'L, Inc. | 1991-03-29 | Traditional | PDF ↗ |
| K905708 | TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM | Trimedyne, Inc. | 1991-03-28 | Traditional | PDF ↗ |
| K904930 | SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH | Directed Energy, Inc. | 1991-03-21 | Traditional | PDF ↗ |
| K903838 | OPTILASE (TM) MODEL 900 ARGON | Trimedyne, Inc. | 1991-03-05 | Traditional | PDF ↗ |
| K905511 | CODMAN NEUROLASE LASER SYSTEM/MODIFICATION | I.L. Med, Inc. | 1991-03-05 | Traditional | PDF ↗ |
| K905424 | KTP DISC KIT | Laserscope | 1991-03-04 | Traditional | PDF ↗ |
| K905006 | SURGILASE SL 150 SURGICAL LASER SYSTEM | Surgilase, Inc. | 1991-02-21 | Traditional | PDF ↗ |
| K904266 | AUTODERM SCANNER CONTROL CONSOLE | Charles I. Rose & Co., Inc. | 1991-02-19 | Traditional | PDF ↗ |
| K903131 | LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM | Lasermatic, Inc. | 1991-02-19 | Traditional | PDF ↗ |
| K904700 | ENDOCOAGULATOR KRS568(TM) LASER | Hgm Medical Laser Systems, Inc. | 1991-02-19 | Traditional | PDF ↗ |
| K905072 | ALTAIR | Pfizer Laser Systems | 1991-02-07 | Traditional | PDF ↗ |
| K903639 | NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR | Nidek, Inc. | 1991-02-04 | Traditional | PDF ↗ |
| K905082 | PEGASUS WITH ACCESSORIES | Pfizer Laser Systems | 1991-01-31 | Traditional | PDF ↗ |
| K904911 | DISPOSABLE FIBER OPTIC DELIVERY SYSTEM | Fiber Delivery Concepts, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K905637 | ILLUMINA MODEL 780 CO2 LASER SYSTEM | Heraeus Lasersonics, Inc. | 1991-01-18 | Traditional | PDF ↗ |
| K905232 | MOOR LASER BLOOD FLOW MONITOR MBF3 | Moor Instruments, Ltd. | 1991-01-11 | Traditional | PDF ↗ |
| K905233 | MOOR LASER BLOOD FLOW MONITOR MBF3D | Moor Instruments, Ltd. | 1991-01-11 | Traditional | PDF ↗ |
| K904627 | CENTAURI YAG LASER SYST, EAR, NOSE , THROAT | Pfizer Laser Systems | 1991-01-07 | Traditional | PDF ↗ |
| K904629 | CENTAURI YAG LASER SYST, UROLOGY | Pfizer Laser Systems | 1991-01-07 | Traditional | PDF ↗ |
| K904628 | CENTAURI YAG LASER SYST, GASTROENTEROLOGY | Pfizer Laser Systems | 1991-01-07 | Traditional | PDF ↗ |
| K904354 | LPI MULILASE YAG/532 SURGICAL LASER SYSTEM | Laser Photonics, Inc. | 1990-12-19 | Traditional | PDF ↗ |
| K904342 | SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A | Hgm Medical Laser Systems, Inc. | 1990-12-19 | Traditional | PDF ↗ |
| K904610 | HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS | Heraeus Lasersonics, Inc. | 1990-12-19 | Traditional | PDF ↗ |
| K904407 | DISPOSABLE FIBER OPTIC DELIVERY SYST/ND: YAG SURG | Fiber Delivery Concepts, Inc. | 1990-12-18 | Traditional | PDF ↗ |
| K904331 | L.P.I. LASER DELIVERY SYSTEM | Laser Photonics, Inc. | 1990-12-17 | Traditional | PDF ↗ |
| K904630 | CENTAURI YAG LASER SYST, OPHTHAMOLOGY | Pfizer Laser Systems | 1990-12-17 | Traditional | PDF ↗ |
| K904444 | MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/1700 | Heraeus Lasersonics, Inc. | 1990-12-13 | Traditional | PDF ↗ |
| K904423 | CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM | Heraeus Lasersonics, Inc. | 1990-12-13 | Traditional | PDF ↗ |
| K904227 | MULTILASE 45 | Laser Photonics, Inc. | 1990-12-12 | Traditional | PDF ↗ |
| K904229 | MULTILASE 60 | Laser Photonics, Inc. | 1990-12-12 | Traditional | PDF ↗ |
| K904203 | SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM | Surgilase, Inc. | 1990-12-07 | Traditional | PDF ↗ |
| K904402 | NIDEK INC. MODEL AC-2000 DERM | Nidek, Inc. | 1990-12-07 | Traditional | PDF ↗ |
| K904149 | FLEXISYS | Dornier Medtech America, Inc. | 1990-12-04 | Traditional | PDF ↗ |
| K903154 | CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER | Trimedyne, Inc. | 1990-11-23 | Traditional | PDF ↗ |
| K904155 | MEDILAS 4060N FIBERTOM(R) SURGICAL LASER | Dornier Medtech America, Inc. | 1990-11-21 | Traditional | PDF ↗ |
| K903943 | MODEL MC 1100 SURGICAL YAG LASER | Klinger Micro-Controle Group | 1990-11-21 | Traditional | PDF ↗ |
| K904067 | LASERSAT CO2 | Satelec | 1990-11-07 | Traditional | PDF ↗ |
| K904126 | VISIRASER | Acorn Group, Inc. | 1990-10-30 | Traditional | PDF ↗ |
| K903936 | SLT CONTACT LASER SYSTEM ND:YAG MEDICAL LASER SYST | Surgical Laser Technologies, Inc. | 1990-10-26 | Traditional | PDF ↗ |
| K904162 | CARBON DIOXIDE FLOWTHROUGH LASER MIXTURES | Norco, Inc. | 1990-10-19 | Traditional | PDF ↗ |
| K903230 | SHARPLAN CO2 LASERS, MODEL NUMBERS 1050 AND 1075 | Sharplan Lasers, Inc. | 1990-10-11 | Traditional | PDF ↗ |
| K903444 | MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 ND:YAG | Heraeus Lasersonics, Inc. | 1990-10-11 | Traditional | PDF ↗ |
| K903079 | ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM) | Luxar Corp. | 1990-10-04 | Traditional | PDF ↗ |
| K902939 | OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM | Trimedyne, Inc. | 1990-10-03 | Traditional | PDF ↗ |
| K902940 | CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM | Trimedyne, Inc. | 1990-10-03 | Traditional | PDF ↗ |
| K900858 | CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES | Candela Laser Corp. | 1990-10-03 | Traditional | PDF ↗ |
| K902133 | MODEL IS102S ND:YAG SURGICAL LASER SYSTEM | Niic U.S.A., Inc. | 1990-10-02 | Traditional | PDF ↗ |
| K902947 | PEGASUS W/ACCESSORIES FOR ARTHROSCOPIC APPLICATION | Pfizer Laser Systems | 1990-10-02 | Traditional | PDF ↗ |
| K902990 | COHERENT HOLMIUM:YAG SURGICAL LASER | Coherent Medical Division | 1990-10-02 | Traditional | PDF ↗ |
| K902946 | PEGASUS W/ACCESSORIES FOR GENERAL SURGERY | Pfizer Laser Systems | 1990-10-02 | Traditional | PDF ↗ |
| K903027 | PEGASUS WITH ACCESSORIES | Pfizer Laser Systems | 1990-10-02 | Traditional | PDF ↗ |
| K902534 | CENTAURI ERBIUM YITTRIUM ALUMINUM GARNET LASER | Pfizer Laser Systems | 1990-09-25 | Traditional | PDF ↗ |
| K903288 | IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED | Iriderm Div. | 1990-09-24 | Traditional | PDF ↗ |
| K902871 | OPTILITE FIBEROPTIC DELIVERY SYSTEMS | Xintec Corporation | 1990-09-24 | Traditional | PDF ↗ |
| K901710 | OPTICA 120 ND:YAG SURGICAL LASER SYSTEM | Xintec Corporation | 1990-09-20 | Traditional | PDF ↗ |
| K903689 | COHERENT DIODE PHOTOCOAGULATOR | Lumenis, Inc. | 1990-09-20 | Traditional | PDF ↗ |
| K903883 | VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES | Metatech Corp. | 1990-09-19 | Traditional | PDF ↗ |
| K900890 | NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA | Nidek, Inc. | 1990-09-10 | Traditional | PDF ↗ |
| K900925 | NIDEK, INC. MODEL ADC-8000 DERM | Nidek, Inc. | 1990-09-10 | Traditional | PDF ↗ |
| K901127 | LASERCOMP MODEL STAR 10 FOR KNEE ARTHROSCOPY | Lasercomp | 1990-09-10 | Traditional | PDF ↗ |
| K903849 | MODEL RD-1200 RUBY LASER SYSTEM | Charles L. Rose and Co., Inc. | 1990-09-05 | Traditional | PDF ↗ |
| K901016 | LASER-SHIELD II(TM) | Xomed, Inc. | 1990-08-29 | Traditional | PDF ↗ |
| K901365 | LASER FORCEPS HANDPIECE | Lca, Inc. | 1990-08-21 | Traditional | PDF ↗ |
| K901205 | MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION) | Niic U.S.A., Inc. | 1990-08-14 | Traditional | PDF ↗ |
| K902470 | COHERENT XA30/SP AND XA50 SURGICAL LASERS | Lumenis, Inc. | 1990-07-26 | Traditional | PDF ↗ |
| K900837 | LPI YAG MODEL 1003 SURGICAL LASER SYSTEM | Laser Photonics, Inc. | 1990-07-12 | Traditional | PDF ↗ |
| K902241 | SLT CONTACT LASER SYSTEMS (UROLOGY) | Surgical Laser Technologies, Inc. | 1990-07-12 | Traditional | PDF ↗ |
| K902148 | MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,1700 | Heraeus Lasersonics, Inc. | 1990-07-10 | Traditional | PDF ↗ |
| K902061 | MODELS 4000,4900,6000,8000,8900,LUXUS 60,100&1700 | Heraeus Lasersonics, Inc. | 1990-07-10 | Traditional | PDF ↗ |
| K902211 | SURGILASE YAG 100 SURGICAL LASER SYSTEM | Surgilase, Inc. | 1990-06-29 | Traditional | PDF ↗ |
| K902058 | ADD'L USE OF THE KTP/YAG SURGICAL LASER | Laserscope | 1990-06-29 | Traditional | PDF ↗ |
| K902063 | NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM | Niic U.S.A., Inc. | 1990-06-29 | Traditional | PDF ↗ |
| K901638 | MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 | Lasermatic, Inc. | 1990-06-27 | Traditional | PDF ↗ |
| K901786 | LASEGUIDE CAT # CLF-600D & CLF-1000D | Laser Peripherals, LLC | 1990-06-27 | Traditional | PDF ↗ |
| K901340 | MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM | Klinger Medical | 1990-06-26 | Traditional | PDF ↗ |
| K901636 | DIAMOND ND:YAG OPHTHALMIC LASER | Biovision, Inc. | 1990-06-22 | Traditional | PDF ↗ |
| K902562 | REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER | Lca, Inc. | 1990-06-20 | Traditional | PDF ↗ |
| K901481 | MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER | Nidek, Inc. | 1990-06-20 | Traditional | PDF ↗ |
| K894241 | MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT | Directed Energy, Inc. | 1990-06-18 | Traditional | PDF ↗ |
| K901204 | EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS | Niic U.S.A., Inc. | 1990-06-05 | Traditional | PDF ↗ |
| K901128 | LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG. | Lasercomp | 1990-06-05 | Traditional | PDF ↗ |
| K901943 | KTP/532 (TM) SURGICAL LASER | Laserscope | 1990-05-29 | Traditional | PDF ↗ |
| K896314 | ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG | Hgm Medical Laser Systems, Inc. | 1990-05-10 | Traditional | PDF ↗ |
| K900630 | MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG | Heraeus Lasersonics, Inc. | 1990-05-04 | Traditional | PDF ↗ |
| K900751 | HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM | Heraeus Lasersonics, Inc. | 1990-05-03 | Traditional | PDF ↗ |
| K901008 | HEXASCAN HANDPIECE | Lihtan Technologies, Inc. | 1990-05-03 | Traditional | PDF ↗ |
| K900539 | MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL | Sunrise Technologies, Inc. | 1990-05-03 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.