Product Code: HJK FDA class 2 21 CFR 886.1385

Lens, Contact, Polymethylmethacrylate, Diagnostic

Ophthalmic

The Polymethylmethacrylate (PMMA) Diagnostic Contact Lens is a rigid, optically clear contact lens temporarily placed on the eye to facilitate detailed biomicroscopic or goniosopic examination of anterior or posterior ocular structures. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance before marketing. The product code is HJK, regulated under 21 CFR 886.1385, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HJK
Device Class: FDA class 2
Regulation Number: 886.1385
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 41 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K201909	RxSight Contact Lens	Sep 10, 2020	Substantially Equivalent	Rxsight, Inc.
K173944	Endocular Viewing Lenses and Silicone Ring	Oct 25, 2018	Substantially Equivalent	Phakos
K151961	Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens	Aug 18, 2015	Substantially Equivalent	Volk Optical, Inc.
K142715	Sensor Medical Family of Vitrectomy Lenses and Products	Dec 16, 2014	Substantially Equivalent	Sensor Medical Technology, LLC
K051630	SUPER VIEW DISPOSABLE BIOM LENS SET	Jun 29, 2005	Substantially Equivalent	Insight Instruments, Inc.
K051103	HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY	Jun 07, 2005	Substantially Equivalent	Haag-Streit USA, Inc.
K050623	VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D	Mar 28, 2005	Substantially Equivalent	Volk Optical, Inc.
K033950	DORC VITRECTOMY LENSES, MODEL 1284 SERIES	Feb 20, 2004	Substantially Equivalent	Dutch Ophthalmic Research Center (D.O.R.C.)
K030054	DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES	Feb 26, 2003	Substantially Equivalent	Fci Ophthalmics, Inc.
K023221	CONTACT LASER & DIAGNOSTIC LENSES	Oct 11, 2002	Substantially Equivalent	Volk Optical, Inc.
K022413	LUNEAU 3 MIRROR LENS	Sep 24, 2002	Substantially Equivalent	Luneau SA
K014170	STAURENGHI WIDE FIELD SCANNING LASER LENS	Mar 04, 2002	Substantially Equivalent	Ocular Instruments, Inc.
K012096	DISPOSABLE VITRECTOMY LENS	Aug 24, 2001	Substantially Equivalent	Ocular Instruments, Inc.
K971853	ENDOVIEW SPPHIRE LENS SET	Aug 06, 1997	Substantially Equivalent	American Medical Devices, Inc.
K933976	MANDELKORN SUTURE LYSIS LENS	Nov 08, 1994	Substantially Equivalent	Ocular Instruments, Inc.
K933264	RITCH NYLON SUTURE LASER LENS	Oct 31, 1994	Substantially Equivalent	Ocular Instruments, Inc.
K940107	VIRECTOMY LENS	Sep 06, 1994	Substantially Equivalent	Visionary Technologies of Miami, Inc.
K943125	QUADRASPHERIC FUNDUS LENS	Sep 02, 1994	Substantially Equivalent	Volk Optical, Inc.
K941420	50 DEGREE HRI PRISM LENS	Aug 29, 1994	Substantially Equivalent	Ocular Instruments, Inc.
K914051	PEDIATRIC VITRECTOMY LENS SET	Dec 09, 1991	Substantially Equivalent	Ocular Instruments, Inc.
K914117	LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET	Nov 13, 1991	Substantially Equivalent	Ocular Instruments, Inc.
K912366	MAINSTER HIGH MAGNIFICATION LASER LENS	Jun 25, 1991	Substantially Equivalent	Ocular Instruments, Inc.
K910231	NMR-K FUNDUS LASER LENS	Jan 28, 1991	Substantially Equivalent	Ocular Instruments, Inc.
K896198	MAINSTER WIDE FIELD LASER LENS	Dec 18, 1989	Substantially Equivalent	Ocular Instruments, Inc.
K894421	WOLDOFF PRISMATIC BICONCAVE LENS	Oct 04, 1989	Substantially Equivalent	Ocular Instruments, Inc.
K875331	BICONCAVE VITRECTOMY LENS	Feb 26, 1988	Substantially Equivalent	Ocular Instruments, Inc.
K875330	HOSKINS-BARKAN GONIOTOMY LENS 10MM	Feb 26, 1988	Substantially Equivalent	Ocular Instruments, Inc.
K875114	HOSKINS-BARKAN GONIOTOMY LENS 9MM	Feb 19, 1988	Substantially Equivalent	Ocular Instruments, Inc.
K875087	PEYMAN G. 12.12 YAG LASER LENS	Feb 19, 1988	Substantially Equivalent	Ocular Instruments, Inc.
K872855	18MM PEYMAN WIDE FIELD YAG LASER LENS	Sep 04, 1987	Substantially Equivalent	Ocular Instruments, Inc.
K872136	12.5MM PEYMAN WIDE FIELD YAG LASER LENS	Jun 19, 1987	Substantially Equivalent	Ocular Instruments, Inc.
K871450	25MM PEYMAN WIDE FIELD YAG LASER LENS	Jun 03, 1987	Substantially Equivalent	Ocular Instruments, Inc.
K864304	YANNUZZI FUNDUS LASER LENS	Dec 15, 1986	Substantially Equivalent	Ocular Instruments, Inc.
K863911	MAINSTER RETINA LASER LENS	Dec 12, 1986	Substantially Equivalent	Ocular Instruments, Inc.
K864418	LANDERS INDIRECT VITRECTOMY LENS	Nov 28, 1986	Substantially Equivalent	Ocular Instruments, Inc.
K863027	SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS	Aug 21, 1986	Substantially Equivalent	Ocular Instruments, Inc.
K862868	ABRAHAM YAG LASER LENS	Aug 21, 1986	Substantially Equivalent	Ocular Instruments, Inc.
K862728	HOSKINS NYLON SUTURE LASER LENS	Aug 21, 1986	Substantially Equivalent	Ocular Instruments, Inc.
K862094	LENS-EZE	Jun 19, 1986	Substantially Equivalent	Insight International, Inc.
K861648	WISE IRIDOTOMY-SPINCTEROTOMY LENS	Jun 19, 1986	Substantially Equivalent	Ocular Instruments, Inc.
K781960	SURGICAL EYE SHIELD	Feb 09, 1979	Substantially Equivalent	Concept, Inc.