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VOLK OPTICAL INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15281421000122772VOLK OPTICAL INC.1N2026-01-017893 ENTERPRISE DR. Mentor OH US 44060

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00811608012872SuperMacula VIT (VSMACVIT) - VSMACVIT4409426161bernie.rykaczewski@volk.com
00811608012872SuperMacula VIT (VSMACVIT) - VSMACVIT440-942-6161snigdha.katragadda@volk.com
00811608012872SuperMacula VIT (VSMACVIT) - VSMACVIT440-942-6161apoorva.agarwal@volk.com
00811608012889Central Retinal Vit (VCRLVIT) - VCRLVIT4409426161bernie.rykaczewski@volk.com
00811608012889Central Retinal Vit (VCRLVIT) - VCRLVIT440-942-6161snigdha.katragadda@volk.com
00811608012889Central Retinal Vit (VCRLVIT) - VCRLVIT440-942-6161apoorva.agarwal@volk.com
00811608012896Mini Quad VIT (VMQVIT) - VMQVIT4409426161bernie.rykaczewski@volk.com
00811608012896Mini Quad VIT (VMQVIT) - VMQVIT440-942-6161snigdha.katragadda@volk.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
425351534122010K943125QUADRASPHERIC FUNDUS LENSHJK1994-09-02
425351743811832K925757OPHTHALMOSCOPEHLJ1993-08-03
425351777565990K201325Optomed Smartscope M5 with Optomed Smartscope FAHKI2020-11-20
425351118463162K180378Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior ModuleHKI2018-04-05
425351630517055K162011MedDreamLLZ2016-10-14
425351201942306K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensHJK2015-08-18
425351211842704K132186OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2HKI2013-12-18
425351499068969K110986OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1HKI2011-05-16
425351447860810K050623VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV DHJK2005-03-28
425351376385257K023221CONTACT LASER & DIAGNOSTIC LENSESHJK2002-10-11
425351060470113
425351361620737
425351410164419
425351415771091
425351458747689
425351546101259
425351801193433
425351840391356
425351840707941
425351868564373
425351920281395
425352073462930

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HKI42020-11-20
HJK42015-08-18
LLZ12016-10-14
HLJ11993-08-03

PMN#

GUDID#

200 records. Showing 1-40. Next