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 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K212763 | UniVit HE, UniVit UHS | Visioncare Devices, LLC | 2022-08-10 | Traditional | PDF ↗ |
| K170183 | Cetus system, Cetus probe | A.R.C Laser GmbH | 2017-09-27 | Traditional | PDF ↗ |
| K153168 | Bi-Blade Vitrectomy Cutter | Medical Instrument Development Laboratories | 2016-04-29 | Special | PDF ↗ |
| K141065 | CONSTELLATION VISION SYSTEM | Alcon Research, Ltd. | 2014-08-22 | Traditional | PDF ↗ |
| K121675 | VERSAVIT | Synergetics, Inc. | 2012-06-21 | Traditional | PDF ↗ |
| K120170 | PROCARE PLUS VITRECTOMY SYSTEM | Visioncare Devices, Inc. | 2012-05-30 | Traditional | PDF ↗ |
| K102222 | ULTIMATE VIT ENHAMCER (UVE) | Medical Instrument Development Laboratories, Inc. | 2011-04-08 | Traditional | PDF ↗ |
| K033390 | COLIBRI DISPOSABLE VITRECTOMY CUTTER | Microworld Medical Instruments, Inc. | 2003-11-04 | Traditional | PDF ↗ |
| K030948 | VMATE MODEL VMM1000 | Howard Instruments, Inc. | 2003-06-17 | Traditional | PDF ↗ |
| K023939 | VELOCITY ADVANTAGE | Visioncare Devices, Inc. | 2003-04-17 | Traditional | PDF ↗ |
| K020911 | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | Medical Instrument Development Laboratories, Inc. | 2002-04-29 | Traditional | PDF ↗ |
| K010082 | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | 2001-03-12 | Traditional | PDF ↗ |
| K992943 | VIT ENHANCER | Medical Instrument Development Laboratories, Inc. | 1999-12-10 | Traditional | PDF ↗ |
| K990292 | I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN | Ophthalmic Consultants, Inc. | 1999-11-19 | Traditional | PDF ↗ |
| K983797 | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | 1999-03-03 | Traditional | PDF ↗ |
| K980399 | PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 | Peregrine Surgical , Ltd. | 1998-04-30 | Traditional | PDF ↗ |
| K980400 | PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 | Peregrine Surgical , Ltd. | 1998-04-30 | Traditional | PDF ↗ |
| K980488 | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM | Storz Instrument Co. | 1998-03-23 | Traditional | PDF ↗ |
| K970670 | REUSABLE VITRECTOMY PROBE | Altex Vision | 1997-05-06 | Traditional | PDF ↗ |
| K970673 | DISPOSABLE VITRECTOMY PROBE | Altex Vision | 1997-05-05 | Traditional | PDF ↗ |
| K964743 | STORZ E8010 ERGOTEC/PREMIERE ADAPTOR | Storz Instrument Co. | 1997-02-03 | Traditional | PDF ↗ |
| K961738 | VIT COMMANDER SYSTEM | Scieran Technologies, Inc. | 1996-11-25 | Traditional | PDF ↗ |
| K960061 | STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE | Storz Instrument Co. | 1996-09-18 | Traditional | PDF ↗ |
| K961078 | AUTOMATED VITRECTOMY DEVICE | Promex, Inc. | 1996-06-14 | Traditional | PDF ↗ |
| K954816 | STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX | Storz Instrument Co. | 1996-03-04 | Traditional | PDF ↗ |
| K953576 | STORZ DP4505 VITREOUS MEMBRANE DISSECTOR | Storz Instrument Co. | 1995-09-14 | Traditional | PDF ↗ |
| K953575 | STORZ MVS-3201 VITRECTOMY PROBE PACK | Storz Instrument Co. | 1995-09-14 | Traditional | PDF ↗ |
| K950852 | CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP) | H.S. Intl. Co., Inc. | 1995-05-19 | Traditional | PDF ↗ |
| K950799 | PRO-VIT | M. Imonti and Associates Inc., | 1995-04-28 | Traditional | PDF ↗ |
| K946135 | INFINITECH ASPIRATING LASER PROBE | Surgical Technologies, Inc. | 1995-04-18 | Traditional | PDF ↗ |
| K946181 | INFINITECH SOFT TIP FLUTE NEEDLE | Surgical Technologies, Inc. | 1995-03-14 | Traditional | PDF ↗ |
| K934600 | MICRODRIVE | Medical Instrument Development Laboratories, Inc. | 1994-07-27 | Traditional | PDF ↗ |
| K936302 | NIDEK MODEL VT-4000, MODIFICATION | Nidek, Inc. | 1994-07-15 | Traditional | PDF ↗ |
| K940391 | PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE | Peregrine Surgical , Ltd. | 1994-06-08 | Traditional | PDF ↗ |
| K940746 | VIT CUTTER MODEL 94 | Visioncare Devices, Inc. | 1994-06-06 | Traditional | PDF ↗ |
| K932669 | SUPRA-VIT(TM) | Medical Instrument Development Laboratories, Inc. | 1994-06-03 | Traditional | PDF ↗ |
| K930842 | THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE | Grieshaber & Co. | 1994-05-03 | Traditional | PDF ↗ |
| K933907 | STORZ FIBEROPTIC PICK MANIPULATOR | Storz Instrument Co. | 1994-03-07 | Traditional | PDF ↗ |
| K932668 | OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER | Synergetics, Inc. | 1994-02-23 | Traditional | PDF ↗ |
| K934204 | INTERTIP INFUSION SET | Oasis Medical, Inc. | 1994-02-07 | Traditional | PDF ↗ |
| K933984 | STORZ FIBEROPTIC REVERSE CUTTING KNIFE | Storz Instrument Co. | 1994-01-25 | Traditional | PDF ↗ |
| K933208 | BARE-FIBER ENDOILLUMINATOR | Surgical Technologies, Inc. | 1993-12-14 | Traditional | PDF ↗ |
| K924353 | NIDEK MODEL VST-4000 | Nidek, Inc. | 1993-03-29 | Traditional | PDF ↗ |
| K924222 | MID LABS, INC. VIT MATE | Medical Instrument Development Laboratories, Inc. | 1993-01-27 | Traditional | PDF ↗ |
| K924604 | STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV | Storz Instrument Co. | 1992-11-27 | Traditional | PDF ↗ |
| K922355 | POLLY'S VITREOUS SCISSORS J-225-S | O.R. Specialties, Inc. | 1992-08-18 | Traditional | PDF ↗ |
| K921758 | STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM | Storz Instrument Co. | 1992-07-16 | Traditional | PDF ↗ |
| K921460 | STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS | Storz Instrument Co. | 1992-07-02 | Traditional | PDF ↗ |
| K920718 | DISPOSABLE POSTERIOR MICROSCISSORS | Storz Instrument Co. | 1992-05-18 | Traditional | PDF ↗ |
| K920582 | 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. | Site Microsurgical Systems, Inc. | 1992-05-08 | Traditional | PDF ↗ |
| K915745 | D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE | Storz Instrument Co. | 1992-03-13 | Traditional | PDF ↗ |
| K913504 | STORZ MICRO CUTTER 25 GAUGE PACK | Storz | 1992-02-21 | Traditional | PDF ↗ |
| K913261 | DWYER EYE SYSTEMS ASPIRATION UNIT | Spectracare, Inc. | 1992-01-30 | Traditional | PDF ↗ |
| K912384 | DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE | Nidek, Inc. | 1991-12-24 | Traditional | PDF ↗ |
| K914038 | POLLY'S CUTTER J-225 | O.R. Specialties, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K913837 | MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM | Vision Medical, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K914221 | KPE 220 TS, NONSTERILE | Ipax, Inc. | 1991-10-25 | Traditional | PDF ↗ |
| K912253 | LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING | Ocular Instruments, Inc. | 1991-08-07 | Traditional | PDF ↗ |
| K911998 | MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM | Allergan Medical Optics | 1991-07-26 | Traditional | PDF ↗ |
| K910973 | DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE | Surgical Technologies, Inc. | 1991-04-26 | Traditional | PDF ↗ |
| K904909 | I/A VITROPHAGE MODEL YPR 2001 | Visioncare Devices, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K895813 | GLAUCOMA MECHANICAL TREPHINE | Trek Medical Products, Inc. | 1990-04-30 | Traditional | PDF ↗ |
| K896943 | SITE DISPOSABLE CUTTER AND ACCESSORIES | Site Microsurgical Systems, Inc. | 1990-03-08 | Traditional | PDF ↗ |
| K894248 | CONVERTER SYSTEM | Mira, Inc. | 1990-02-27 | Traditional | PDF ↗ |
| K896754 | I/A HANDPIECE | Advanced Surgical Products, Inc. | 1990-01-11 | Traditional | PDF ↗ |
| K896305 | MULTI-USE I/A HANDPIECE | Advanced Surgical Products, Inc. | 1989-12-18 | Traditional | PDF ↗ |
| K894278 | STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS | Storz Instrument Co. | 1989-08-11 | Traditional | PDF ↗ |
| K890195 | JAMES SURGICAL SYSTEM J1000 | O.R. Specialties, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K891601 | POWER OPERATED AND CONTROLLED VITREOUS SCISSORS | Mira, Inc. | 1989-05-23 | Traditional | PDF ↗ |
| K884557 | ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE | Advanced Surgical Products, Inc. | 1989-05-12 | Traditional | PDF ↗ |
| K890622 | SURG-E-TROL SYSTEM I AND SYSTEM II | Mentor O & O, Inc. | 1989-05-04 | Traditional | PDF ↗ |
| K890300 | INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE | CooperVision, Inc. | 1989-04-17 | Traditional | PDF ↗ |
| K890133 | OCULAR CONNECTION MACHINE(TM) | Innovision Medical, Inc. | 1989-04-12 | Traditional | PDF ↗ |
| K890544 | SHAPIRO CUTTER | H.S. Intl. Co., Inc. | 1989-02-28 | Traditional | PDF ↗ |
| K884556 | DREYER CURVED ENDOILLUMINATOR | Advanced Surgical Products, Inc. | 1989-02-28 | Traditional | PDF ↗ |
| K885196 | LASER INDIRECT OPHTHALMOSCOPE (LIO) | Coherent Medical Group | 1989-01-11 | Traditional | PDF ↗ |
| K884043 | GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE | Grieshaber & Co. | 1988-11-16 | Traditional | PDF ↗ |
| K883926 | .2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND. | Site Microsurgical Systems, Inc. | 1988-11-15 | Traditional | PDF ↗ |
| K883605 | MODIFIED REUSABLE SITE FIBER OPTIC CABLE | Site Microsurgical Systems, Inc. | 1988-10-25 | Traditional | PDF ↗ |
| K883975 | DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. | Site Microsurgical Systems, Inc. | 1988-10-25 | Traditional | PDF ↗ |
| K881519 | VAC-G (GUILLOTINE VITRECTOR) | B&B Medical Assoc., Inc. | 1988-09-08 | Traditional | PDF ↗ |
| K881520 | VAC (OSCILLATING VITRECTOR) | B&B Medical Assoc., Inc. | 1988-09-07 | Traditional | PDF ↗ |
| K880943 | MICROLINE CAT #100 | Microline Pentax, Inc. | 1988-05-26 | Traditional | PDF ↗ |
| K880929 | NIDEK CV-4000 | Nidek, Inc. | 1988-05-25 | Traditional | PDF ↗ |
| K881927 | PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES | Advanced Surgical Products, Inc. | 1988-05-25 | Traditional | PDF ↗ |
| K880968 | MODEL 2001 PHACOEMULSIFIER ASPIRATOR | Mcghan Instrumed Corp. | 1988-04-19 | Traditional | PDF ↗ |
| K872312 | MODEL 3000 OPHTHALMIC SURGICAL SYSTEM | Allergan Humphrey | 1987-07-15 | Traditional | PDF ↗ |
| K871871 | SERIES TEN THOUSAND OCUTOME | CooperVision, Inc. | 1987-06-11 | Traditional | PDF ↗ |
| K871375 | SITE PERISTALTIC MODULE SYSTEM | Site Microsurgical Systems, Inc. | 1987-05-07 | Traditional | PDF ↗ |
| K870775 | ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE | Entravision, Inc. | 1987-03-26 | Traditional | PDF ↗ |
| K870068 | ASPIRATION REVERSAL CONTROL (ARC) MODULE | Optical Micro Systems, Inc. | 1987-02-12 | Traditional | PDF ↗ |
| K864035 | VES-10 INTRAOCULAR SCISSORS DRIVE | Trek Medical Products, Inc. | 1986-12-15 | Traditional | PDF ↗ |
| K862943 | SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE | Site Microsurgical Systems, Inc. | 1986-08-21 | Traditional | PDF ↗ |
| K862188 | IRRIGATION & ASPIRATION/VITRECTOMY DEVICE | Coburn Optical Ind., Inc. | 1986-08-21 | Traditional | PDF ↗ |
| K861565 | SERIES TEN THOUSAND COMPACT | CooperVision, Inc. | 1986-07-11 | Traditional | PDF ↗ |
| K861380 | SERIES TEN THOUSAND MASTER | CooperVision, Inc. | 1986-07-11 | Traditional | PDF ↗ |
| K862343 | VACUUM HANDLE MODEL I/A - 1 | Cutler Medical Instruments | 1986-07-11 | Traditional | PDF ↗ |
| K860891 | AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE | Intra-Optics Labs. C/O Newman Assoc. | 1986-04-21 | Traditional | PDF ↗ |
| K860014 | SYSTEMS PLUS | United Surgical Corp. | 1986-03-05 | Traditional | PDF ↗ |
| K854868 | I/A - VFE SYSTEM II | Mira, Inc. | 1986-02-07 | Traditional | PDF ↗ |
Product code HQE · Class II · Ophthalmic. Data: openFDA.