HJK — Lens, Contact, Polymethylmethacrylate, Diagnostic Class II
FDA product code HJK covers "Lens, Contact, Polymethylmethacrylate, Diagnostic", a Class II medical device regulated under 21 CFR 886.1385. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HJK
- Device Class
- Class II
- Regulation Number
- 886.1385
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201909 | rxsight | RxSight Contact Lens | September 10, 2020 |
| K173944 | phakos | Endocular Viewing Lenses and Silicone Ring | October 25, 2018 |
| K151961 | volk optical | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | August 18, 2015 |
| K142715 | sensor medical technology | Sensor Medical Family of Vitrectomy Lenses and Products | December 16, 2014 |
| K051630 | insight instruments | SUPER VIEW DISPOSABLE BIOM LENS SET | June 29, 2005 |
| K051103 | haag-streit usa | HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY | June 7, 2005 |
| K050623 | volk optical | VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK | March 28, 2005 |
| K033950 | dutch ophthalmic research center (d.o.r.c.) | DORC VITRECTOMY LENSES, MODEL 1284 SERIES | February 20, 2004 |
| K030054 | fci ophthalmics | DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES | February 26, 2003 |
| K023221 | volk optical | CONTACT LASER & DIAGNOSTIC LENSES | October 11, 2002 |
| K022413 | luneau | LUNEAU 3 MIRROR LENS | September 24, 2002 |
| K014170 | ocular instruments | STAURENGHI WIDE FIELD SCANNING LASER LENS | March 4, 2002 |
| K012096 | ocular instruments | DISPOSABLE VITRECTOMY LENS | August 24, 2001 |
| K971853 | american medical devices | ENDOVIEW SPPHIRE LENS SET | August 6, 1997 |
| K933976 | ocular instruments | MANDELKORN SUTURE LYSIS LENS | November 8, 1994 |
| K933264 | ocular instruments | RITCH NYLON SUTURE LASER LENS | October 31, 1994 |
| K940107 | visionary technologies of miami | VIRECTOMY LENS | September 6, 1994 |
| K943125 | volk optical | QUADRASPHERIC FUNDUS LENS | September 2, 1994 |
| K941420 | ocular instruments | 50 DEGREE HRI PRISM LENS | August 29, 1994 |
| K914051 | ocular instruments | PEDIATRIC VITRECTOMY LENS SET | December 9, 1991 |