FDA Product Code
FDA Product Code HQE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4150
510(k) Clearances — 149 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K834162 | VIT PAC | American Surgical Co., Inc. | 1986-02-07 | Traditional | PDF ↗ |
| K854871 | MICRO SURGICAL SYSTEM | Mira, Inc. | 1986-02-07 | Traditional | PDF ↗ |
| K834160 | VITREONIC PLUS | American Surgical Co., Inc. | 1986-02-07 | Traditional | PDF ↗ |
| K854508 | STORZ DAISY | Storz Instrument Co. | 1986-02-04 | Traditional | PDF ↗ |
| K853430 | STORZ IAS DISPOSABLE PACK | Storz Instrument Co. | 1985-12-16 | Traditional | PDF ↗ |
| K853961 | VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 | Visitec Co. | 1985-12-13 | Traditional | PDF ↗ |
| K853457 | COBURN I/A SYSTEM | Coburn Optical Ind., Inc. | 1985-10-15 | Traditional | PDF ↗ |
| K853308 | KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 | Frigitronics of Connecticut, Inc. | 1985-10-04 | Traditional | PDF ↗ |
| K853382 | MAID MENTOR ASPIRATION/IRRIGATION DEVRO | Mentor O & O, Inc. | 1985-10-04 | Traditional | PDF ↗ |
| K851936 | STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT | Staar Surgical Co. | 1985-08-20 | Traditional | PDF ↗ |
| K852271 | CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001 | CooperVision, Inc. | 1985-08-09 | Traditional | PDF ↗ |
| K853135 | VISITEC 2 MICRON FLUID FILTER | Visitec Co. | 1985-08-09 | Traditional | PDF ↗ |
| K851610 | COMBINED MVS SYSTEMS | Medical Instrument Development Laboratories, Inc. | 1985-07-22 | Traditional | PDF ↗ |
| K851272 | VERSAPHAGE | Alphamedix, Inc. | 1985-07-05 | Traditional | PDF ↗ |
| K843594 | AIRVIT MODEL 8500 | Lasermed Corp. | 1985-04-11 | Traditional | PDF ↗ |
| K850857 | I/A HANDPIECE | Medical Instrument Development Laboratories, Inc. | 1985-03-29 | Traditional | PDF ↗ |
| K844715 | VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY | Optical Micro Systems, Inc. | 1985-01-22 | Traditional | PDF ↗ |
| K843391 | INFUSION ASPIRATION VITRECTOMY SYS | Medical Instrument Development Laboratories, Inc. | 1984-12-19 | Traditional | PDF ↗ |
| K842793 | MVS XII | Medical Instrument Development Laboratories, Inc. | 1984-12-19 | Traditional | PDF ↗ |
| K844510 | OMS SCISSORS | Optical Micro Systems, Inc. | 1984-12-11 | Traditional | PDF ↗ |
| K844374 | O.M.S. GUILLOTINE CUTTER | Optical Micro Systems, Inc. | 1984-12-11 | Traditional | PDF ↗ |
| K842188 | MULTIPLE-LENS, SPECTACLES, CUSTOM | Gold Cadillac Co. | 1984-12-11 | Traditional | PDF ↗ |
| K842471 | AUTOMATED INTRAOCULAR SCISSORS | Medical Instrument Development Laboratories, Inc. | 1984-11-21 | Traditional | PDF ↗ |
| K843041 | HESLIN DISPOS. TUBING SET | Innovative Surgical Products, Inc. | 1984-11-21 | Traditional | PDF ↗ |
| K841738 | AMER. SURGICAL CORP. EXTRA PLUS PAK | American Surgical Co., Inc. | 1984-10-05 | Traditional | PDF ↗ |
| K842197 | AMERICAN MEDICAL OPTICS I/A KIT- IRRIG | American Medical Optics | 1984-10-01 | Traditional | PDF ↗ |
| K834155 | UNIVERSAL PACK | Atlantic Optical Systems, Inc. | 1984-06-19 | Traditional | PDF ↗ |
| K834437 | KEATES IRRIGATION/ASPIRATION/VITREOUS | Frigitronics of Connecticut, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K832703 | ARGON LASER SYS-MODEL 5000 | Cooper Medical Corp. | 1984-01-30 | Traditional | PDF ↗ |
| K833371 | DISPOSABLE OCUTOME PROBE | CooperVision, Inc. | 1984-01-04 | Traditional | PDF ↗ |
| K834163 | ULTRAVIT | American Surgical Co., Inc. | 1983-12-28 | Traditional | PDF ↗ |
| K832446 | CATAREX DIAP. EXTRACAPSULAR CATARACT | Calliope Corp. | 1983-10-19 | Traditional | PDF ↗ |
| K832235 | DISPOSABLE VITRECTOMY HANDPIECE | Innovative Surgical Products, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K831584 | BAILEY ASPIRATOR/IRRIGATOR | Medical Instrument Development Laboratories, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K830037 | EXTENSION HANDLE FOR ACUTOME PROBE | Precision Medical Instruments, Inc. | 1983-04-06 | Traditional | PDF ↗ |
| K830216 | DORC COMPACT MICRO SURGICAL SYSTEM | Jedmed Instrument Co. | 1983-03-09 | Traditional | PDF ↗ |
| K822220 | COOPER VISION I/A SYSTEM III MODEL 1500 | CooperVision, Inc. | 1982-10-06 | Traditional | PDF ↗ |
| K820933 | CILCO I/A HANDPIECE | Cilco, Inc. | 1982-06-14 | Traditional | PDF ↗ |
| K820008 | VERSATOME I | Alphamedix, Inc. | 1982-02-22 | Traditional | PDF ↗ |
| K812857 | CHARLES MICRO PROBE | Mid Laboratories, Inc. | 1982-02-05 | Traditional | PDF ↗ |
| K820026 | VITRE CON | Medical Instrument Development Laboratories, Inc. | 1982-02-05 | Traditional | PDF ↗ |
| K813274 | BLOOD POOL & SUBVETINAL FLUID ASPIRATOR | Optical Micro Systems, Inc. | 1982-02-05 | Traditional | PDF ↗ |
| K813389 | ULTRASONIC FRAGMENTOR | Fibra Sonics, Inc. | 1982-02-04 | Traditional | PDF ↗ |
| K813500 | OMS INFUSION-ASPIRATION HANDLE | Optical Micro Systems, Inc. | 1982-02-04 | Traditional | PDF ↗ |
| K801850 | CHARLES PNEUMATIC INTRAOCULAR SCISSORS | Cooper Medical Devices Corp. | 1980-09-16 | Traditional | PDF ↗ |
| K800110 | X-FLO | Contemporary Surgical Systems, Inc. | 1980-02-06 | Traditional | PDF ↗ |
| K791212 | VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG | Precision Medical Instruments, Inc. | 1979-08-10 | Traditional | PDF ↗ |
| K781471 | PNEUMATIC VITRECTOMY CONTROL UNIT | Helfgott Medical Instruments | 1978-11-08 | Traditional | PDF ↗ |
| K771711 | BIOTOME | Berkeley Bio-Engineering | 1977-09-28 | Traditional | PDF ↗ |
Product code HQE · Class II · Ophthalmic. Data: openFDA.