Product code HJK— Ophthalmic
12.5MM PEYMAN WIDE FIELD YAG LASER LENS
- Classification name
- Lens, Contact, Polymethylmethacrylate, Diagnostic
- Device class
- Class 2
- Regulation
- 21 CFR 886.1385
- Advisory panel
- Ophthalmic
- Total cleared
- 41
- First cleared
- Most recent
Market context for product code HJK
FDA has cleared devices under product code HJK between 1979 and 2020, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2020
- 2018
- 2015
- 2014
- 2005
- 2004
- 2003
- 2002
- 2001
- 1997
- 1994
- 1991
- 1989
- 1988
- 1987
Top applicants under product code HJK
Recent clearances under product code HJK
- K201909 — RxSight Contact Lens
- K173944 — Endocular Viewing Lenses and Silicone Ring
- K151961 — Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
- K142715 — Sensor Medical Family of Vitrectomy Lenses and Products
- K051630 — SUPER VIEW DISPOSABLE BIOM LENS SET
- K051103 — HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
- K050623 — VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
- K033950 — DORC VITRECTOMY LENSES, MODEL 1284 SERIES
- K030054 — DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
- K023221 — CONTACT LASER & DIAGNOSTIC LENSES
- K022413 — LUNEAU 3 MIRROR LENS
- K014170 — STAURENGHI WIDE FIELD SCANNING LASER LENS
- K012096 — DISPOSABLE VITRECTOMY LENS
- K971853 — ENDOVIEW SPPHIRE LENS SET
- K933976 — MANDELKORN SUTURE LYSIS LENS
- K933264 — RITCH NYLON SUTURE LASER LENS
- K940107 — VIRECTOMY LENS
- K943125 — QUADRASPHERIC FUNDUS LENS
- K941420 — 50 DEGREE HRI PRISM LENS
- K914051 — PEDIATRIC VITRECTOMY LENS SET
- K914117 — LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET
- K912366 — MAINSTER HIGH MAGNIFICATION LASER LENS
- K910231 — NMR-K FUNDUS LASER LENS
- K896198 — MAINSTER WIDE FIELD LASER LENS
- K894421 — WOLDOFF PRISMATIC BICONCAVE LENS
- K875330 — HOSKINS-BARKAN GONIOTOMY LENS 10MM
- K875331 — BICONCAVE VITRECTOMY LENS
- K875087 — PEYMAN G. 12.12 YAG LASER LENS
- K875114 — HOSKINS-BARKAN GONIOTOMY LENS 9MM
- K872855 — 18MM PEYMAN WIDE FIELD YAG LASER LENS
- K872136 — 12.5MM PEYMAN WIDE FIELD YAG LASER LENS
- K871450 — 25MM PEYMAN WIDE FIELD YAG LASER LENS
- K864304 — YANNUZZI FUNDUS LASER LENS
- K863911 — MAINSTER RETINA LASER LENS
- K864418 — LANDERS INDIRECT VITRECTOMY LENS
- K862728 — HOSKINS NYLON SUTURE LASER LENS
- K862868 — ABRAHAM YAG LASER LENS
- K863027 — SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS
- K861648 — WISE IRIDOTOMY-SPINCTEROTOMY LENS
- K862094 — LENS-EZE
- K781960 — SURGICAL EYE SHIELD
Data sourced from openFDA. This site is unofficial and independent of the FDA.