Data / Medical devices / United States / Ocular Instruments, Inc.
Ocular Instruments, Inc.: FDA-registered device maker in Bellevue, WA, United States, 37 510(k) clearances
Ocular Instruments, Inc. is registered with the FDA (registration 3014865) in Bellevue, WA, United States. It lists 9 device types. The FDA files 37 510(k) clearances under its listings, the newest dated March 4, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014865
- Address
- 2255 116TH Ave., N.E., Bellevue, WA, United States, 98004
- Owner or operator
- OCULAR INSTRUMENTS (3014865)
- Roles
- Manufacturer
- First device listed
- June 29, 1992
- Registered through
- 2026
- Brand names listed
- O2M-2-Two Mirror Gonio Diagnostic Lens NMR-Kapetensky, O2M-Two Mirror Gonio Diagnostic Lens, O2MA-2-Two Mirror Gonio Laser Lens NMR-Kapetensky, O2MA-Two Mirror Gonio Laser Lens, O2MF-Two Mirror Gonio Diagnostic Lens w/Flange, O2MFA-Two Mirror Gonio Laser Lens w/ Flange, O4GF-Four Mirror Mini Gonio Diagnostic Lens, O4GF-LR-Four Mirror Mini Gonio Diagnostic Lens w/Large Ring and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Eye, Artificial, Non-Custom | HQH | 1 | Manufacturer | accessdata.fda.gov |
| Keratoprosthesis, Temporary Implant, Surgical Use | MLP | 2 | Manufacturer | accessdata.fda.gov |
| Lens, Condensing, Diagnostic | HJL | 1 | Manufacturer | accessdata.fda.gov |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | 2 | Manufacturer | accessdata.fda.gov |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | 1 | Manufacturer | accessdata.fda.gov |
| Prism, Gonioscopic | HKS | 1 | Manufacturer | accessdata.fda.gov |
| Ring, Ophthalmic (Flieringa) | HNH | 1 | Manufacturer | accessdata.fda.gov |
| Tonometer, Manual | HKY | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 4, 2002 | K014170 | STAURENGHI WIDE FIELD SCANNING LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| August 24, 2001 | K012096 | DISPOSABLE VITRECTOMY LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| November 8, 1994 | K933976 | MANDELKORN SUTURE LYSIS LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| October 31, 1994 | K933264 | RITCH NYLON SUTURE LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| August 29, 1994 | K941420 | 50 DEGREE HRI PRISM LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| April 1, 1994 | K935302 | OSHER SURGICAL GONIO/POSTERIOR POLE LENS | HKS | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| December 9, 1991 | K914051 | PEDIATRIC VITRECTOMY LENS SET | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| November 13, 1991 | K914117 | LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| August 21, 1991 | K910828 | LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS | MLP | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| August 7, 1991 | K912269 | LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING | HNH | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| August 7, 1991 | K912268 | LANDERS NOTCHED VITRECTOMY LENS RING | HNH | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| July 25, 1991 | K912151 | LANDERS THREE STRUT VITRECTOMY LENS RING | HNH | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| June 25, 1991 | K912366 | MAINSTER HIGH MAGNIFICATION LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| January 28, 1991 | K910231 | NMR-K FUNDUS LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| July 24, 1990 | K902496 | LANDERS VITRECTOMY LENS RING W/INFUSION | HNH | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| December 18, 1989 | K896198 | MAINSTER WIDE FIELD LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| December 18, 1989 | K895846 | TWO MIRROR GONIO LENS | HKS | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| October 31, 1989 | K895013 | COBO TEMPORARY KERATOPROSTHESIS | MLP | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| October 4, 1989 | K894421 | WOLDOFF PRISMATIC BICONCAVE LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| February 26, 1988 | K875331 | BICONCAVE VITRECTOMY LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| February 26, 1988 | K875330 | HOSKINS-BARKAN GONIOTOMY LENS 10MM | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| February 19, 1988 | K875114 | HOSKINS-BARKAN GONIOTOMY LENS 9MM | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| February 19, 1988 | K875087 | PEYMAN G. 12.12 YAG LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| September 4, 1987 | K872855 | 18MM PEYMAN WIDE FIELD YAG LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| June 19, 1987 | K872136 | 12.5MM PEYMAN WIDE FIELD YAG LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| June 3, 1987 | K871450 | 25MM PEYMAN WIDE FIELD YAG LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| December 15, 1986 | K864304 | YANNUZZI FUNDUS LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| December 12, 1986 | K863911 | MAINSTER RETINA LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| November 28, 1986 | K864418 | LANDERS INDIRECT VITRECTOMY LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| August 21, 1986 | K863027 | SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| August 21, 1986 | K862868 | ABRAHAM YAG LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| August 21, 1986 | K862728 | HOSKINS NYLON SUTURE LASER LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| August 21, 1986 | K862713 | ABRAHAM IRIDECTOMY LENS (YAG LASER) | HKS | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| August 21, 1986 | K862692 | KARICKHOFF DIAGNOSTIC/LASER LENS | HKS | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| July 11, 1986 | K862512 | RITCH TRABECULOPLASTY LASER LENS | HKS | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| June 19, 1986 | K861648 | WISE IRIDOTOMY-SPINCTEROTOMY LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
| March 29, 1985 | K850991 | LANDERS VITRECTOMY LENS RING SYSTEMS | HNH | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact, Polymethylmethacrylate, Diagnostic
- All makers of Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
- All makers of Ring, Ophthalmic (Flieringa)
- All makers of Tonometer, Manual
- All makers of Lens, Condensing, Diagnostic
Updated March 4, 2002. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.