Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens

FDA 510(k) clearance K151961 · decided 2015-08-18

Clearance details

K-number: K151961
Device name: Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
Applicant: Volk Optical, Inc.
Decision: Substantially Equivalent
Date received: 2015-07-16
Decision date: 2015-08-18
Days to decision: 33 days
Clearance type: Special
Product code: HJK
Device class: 2
Regulation number: 886.1385
Medical specialty: Ophthalmic
Advisory committee: Ophthalmic
Location: Mentor, OH, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
RxSight Contact Lens (K201909)	Rxsight, Inc.	2020-09-10
Endocular Viewing Lenses and Silicone Ring (K173944)	Phakos	2018-10-25
Sensor Medical Family of Vitrectomy Lenses and Products (K142715)	Sensor Medical Technology, LLC	2014-12-16
SUPER VIEW DISPOSABLE BIOM LENS SET (K051630)	Insight Instruments, Inc.	2005-06-29
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY (K051103)	Haag-Streit USA, Inc.	2005-06-07
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D (K050623)	Volk Optical, Inc.	2005-03-28
DORC VITRECTOMY LENSES, MODEL 1284 SERIES (K033950)	Dutch Ophthalmic Research Center (D.O.R.C.)	2004-02-20
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (K030054)	Fci Ophthalmics, Inc.	2003-02-26
CONTACT LASER & DIAGNOSTIC LENSES (K023221)	Volk Optical, Inc.	2002-10-11
LUNEAU 3 MIRROR LENS (K022413)	Luneau SA	2002-09-24
STAURENGHI WIDE FIELD SCANNING LASER LENS (K014170)	Ocular Instruments, Inc.	2002-03-04
DISPOSABLE VITRECTOMY LENS (K012096)	Ocular Instruments, Inc.	2001-08-24

No recalls on record reference this clearance.