Data / Medical devices / United States / Volk Optical Inc.

Volk Optical Inc.: FDA-registered device maker in Mentor, OH, United States, 10 510(k) clearances

Name: Volk Optical Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Volk Optical Inc. is registered with the FDA (registration 1528142) in Mentor, OH, United States. It lists 16 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 20, 2020. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Volk Optical Inc.

FDA registration number: 1528142
FEI number: 1000122772
Address: 7893 Enterprise DR., Mentor, OH, United States, 44060
Owner or operator: VOLK OPTICAL INC. (9000705)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: August 16, 2001
Registered through: 2026
Brand names listed: 14D Large Clear (V14LC), 15 Prism SSV ACS (VPRISMSSVACS), 15D Large Clear (V15LC), 20D ACS PermaView (V20LCACSPV), 20D Large Clear (V20LC), 20D Limited Edition #2 (V20LC-LE2), 20D Limited Edition (V20LC-LE), 25D Large Clear (V25LC) and more

Devices it lists

Device	Product code	Class	Role	Source
Camera, Ophthalmic, Ac-Powered	HKI	2	Repackager or relabeler	accessdata.fda.gov
Camera, Ophthalmic, General-Use	PJZ	2	Manufacturer	accessdata.fda.gov
Device, Irrigation, Ocular Surgery	KYG	1	Manufacturer	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Manufacturer	accessdata.fda.gov
Lens, Condensing, Diagnostic	HJL	1	Manufacturer	accessdata.fda.gov
Lens, Contact, Polymethylmethacrylate, Diagnostic	HJK	2	Manufacturer	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Repackager or relabeler	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Microscope, Surgical, General & Plastic Surgery	FSO	1	Manufacturer	accessdata.fda.gov
NSX	NSX		Specification developer	accessdata.fda.gov
Ophthalmoscope, Battery-Powered	HLJ	2	Repackager or relabeler	accessdata.fda.gov
Otoscope	ERA	1	Repackager or relabeler	accessdata.fda.gov
Prism, Gonioscopic	HKS	1	Manufacturer	accessdata.fda.gov
Ring, Ophthalmic (Flieringa)	HNH	1	Manufacturer	accessdata.fda.gov
Stand, Instrument, Ophthalmic, Non-Powered	HMG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 20, 2020	K201325	Optomed Smartscope M5 with Optomed Smartscope FA	HKI	Substantially Equivalent	Optomed Oyj	accessdata.fda.gov
April 5, 2018	K180378	Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module	HKI	Substantially Equivalent	Optomed OY	accessdata.fda.gov
October 14, 2016	K162011	MedDream	LLZ	Substantially Equivalent	Softneta Uab	accessdata.fda.gov
August 18, 2015	K151961	Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens	HJK	Substantially Equivalent	Volk Optical, Inc.	accessdata.fda.gov
December 18, 2013	K132186	OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2	HKI	Substantially Equivalent	Optomed OY	accessdata.fda.gov
May 16, 2011	K110986	OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1	HKI	Substantially Equivalent	Optomed OY	accessdata.fda.gov
March 28, 2005	K050623	VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D	HJK	Substantially Equivalent	Volk Optical, Inc.	accessdata.fda.gov
October 11, 2002	K023221	CONTACT LASER & DIAGNOSTIC LENSES	HJK	Substantially Equivalent	Volk Optical, Inc.	accessdata.fda.gov
September 2, 1994	K943125	QUADRASPHERIC FUNDUS LENS	HJK	Substantially Equivalent	Volk Optical, Inc.	accessdata.fda.gov
August 3, 1993	K925757	OPHTHALMOSCOPE	HLJ	Substantially Equivalent	Rudolf Riester GmbH & Co. KG	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 2, 2016	73213	Class III	Terminated	Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retin	The firm discovered that the incorrect lot number was engraved on the product.	accessdata.fda.gov
February 27, 2015	71048	Class III	Terminated	Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.	Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.	accessdata.fda.gov
February 27, 2015	71014	Class III	Terminated	Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular	Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.	accessdata.fda.gov
October 25, 2012	64410	Class III	Terminated	20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.	The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205).	accessdata.fda.gov
January 23, 2009	52461	Not yet classified	Terminated	Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.	Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the Ball-Seal bushing assembly. As a result, the set screw becomes disengaged from the set screw groove in the bushing assembly and the Lens Positioning Unit slides downward.	accessdata.fda.gov
June 30, 2008	52453	Not yet classified	Terminated	G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.	The ring of the Gonio lenses distributed was engraved as, 'G4 High Mag Gonio LNF'; however, the engraving should have read simply: 'G4 High Mag Gonio.'	accessdata.fda.gov

Compare with other makers

Updated November 20, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.