HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic
Ophthalmic · 21 CFR 886.1385 · Class 2
Overview
| Product Code | HJK |
|---|---|
| Device Name | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Regulation | 21 CFR 886.1385 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 41)
Showing 20 most recent of 41 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201909 | RxSight Contact Lens | Rxsight, Inc. | Sep 10, 2020 | SESE |
| K173944 | Endocular Viewing Lenses and Silicone Ring | Phakos | Oct 25, 2018 | SESE |
| K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | Volk Optical, Inc. | Aug 18, 2015 | SESE |
| K142715 | Sensor Medical Family of Vitrectomy Lenses and Products | Sensor Medical Technology, LLC | Dec 16, 2014 | SESE |
| K051630 | SUPER VIEW DISPOSABLE BIOM LENS SET | Insight Instruments, Inc. | Jun 29, 2005 | SESE |
| K051103 | HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY | Haag-Streit USA, Inc. | Jun 7, 2005 | SESE |
| K050623 | VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D | Volk Optical, Inc. | Mar 28, 2005 | SESE |
| K033950 | DORC VITRECTOMY LENSES, MODEL 1284 SERIES | Dutch Ophthalmic Research Center (D.O.R.C.) | Feb 20, 2004 | SESE |
| K030054 | DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES | Fci Ophthalmics, Inc. | Feb 26, 2003 | SESE |
| K023221 | CONTACT LASER & DIAGNOSTIC LENSES | Volk Optical, Inc. | Oct 11, 2002 | SESE |
| K022413 | LUNEAU 3 MIRROR LENS | Luneau SA | Sep 24, 2002 | SESE |
| K014170 | STAURENGHI WIDE FIELD SCANNING LASER LENS | Ocular Instruments, Inc. | Mar 4, 2002 | SESE |
| K012096 | DISPOSABLE VITRECTOMY LENS | Ocular Instruments, Inc. | Aug 24, 2001 | SESE |
| K971853 | ENDOVIEW SPPHIRE LENS SET | American Medical Devices, Inc. | Aug 6, 1997 | SESE |
| K933976 | MANDELKORN SUTURE LYSIS LENS | Ocular Instruments, Inc. | Nov 8, 1994 | SESE |
| K933264 | RITCH NYLON SUTURE LASER LENS | Ocular Instruments, Inc. | Oct 31, 1994 | SESE |
| K940107 | VIRECTOMY LENS | Visionary Technologies of Miami, Inc. | Sep 6, 1994 | SESE |
| K943125 | QUADRASPHERIC FUNDUS LENS | Volk Optical, Inc. | Sep 2, 1994 | SESE |
| K941420 | 50 DEGREE HRI PRISM LENS | Ocular Instruments, Inc. | Aug 29, 1994 | SESE |
| K914051 | PEDIATRIC VITRECTOMY LENS SET | Ocular Instruments, Inc. | Dec 9, 1991 | SESE |
Top Applicants
- Ocular Instruments, Inc. — 25 clearances
- Volk Optical, Inc. — 4 clearances
- American Medical Devices, Inc. — 1 clearance
- Concept, Inc. — 1 clearance
- Dutch Ophthalmic Research Center (D.O.R.C.) — 1 clearance
