FDA.reportPublic FDA data

Central Retinal SSV ACS (VCRLVITSSVACS)

Primary DI
00811608013008
Brand
Central Retinal SSV ACS (VCRLVITSSVACS)
Company
VOLK OPTICAL INC.
Model
VCRLVITSSVACS
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJKLens, Contact, Polymethylmethacrylate, DiagnosticOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023221000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023221000CONTACT LASER & DIAGNOSTIC LENSESVolk Optical, Inc.2002-10-11HJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811608013008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811608013008008116080130088116080130080811608013008

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy contact lens, reusableA non-sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), It is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a reusable device that must be sterilized before application.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4409426161bernie.rykaczewski@volk.com
440-942-6161snigdha.katragadda@volk.com
440-942-6161apoorva.agarwal@volk.com

Regulatory Flags#

DUNS number
071125835
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811608019970Mounting Kit, for Kaps SOM62121722026-04-27
00811608019987ROLS Adapter Kit, for Kaps122692026-04-27
00811608019994Single Use GonioPro Surgical Lens Sample Box (VSGSAMPLEBOX)VSGSAMPLEBOX2026-04-07
00811608012872SuperMacula VIT (VSMACVIT)VSMACVIT2016-09-29
00811608012889Central Retinal Vit (VCRLVIT)VCRLVIT2016-09-29
00811608012896Mini Quad VIT (VMQVIT)VMQVIT2016-09-29
00811608012902Dynaview 156 VIT (VDVVIT)VDVVIT2016-09-29
00811608012919Mini Quad XL VIT (VMQXLVIT)VMQXLVIT2016-09-29
00811608012971Central Retinal SSV (VCRLVITSSV)VCRLVITSSV2016-09-28
00811608012988Mini Quad SSV (VMQVITSSV)VMQVITSSV2016-09-28
00811608012995Mini Quad XL VIT SSV (VMQXLVITSSV)VMQXLVITSSV2016-09-29
00811608013053HRX Vit (VHRXVIT)VHRXVIT2016-09-29
00811608013060HRX SSV Vit (VHRXVITSSV)VHRXVITSSV2016-09-28
00811608013305HR Direct 1X Vit (VHRD1XACS)VHRD1XACS2016-09-29
00811608013312HR Direct 1X NSR Vit (VHRD1XNSRACS)VHRD1XNSRACS2016-09-29
00811608013336HR Direct Bi-Concave (VHRDBCACS)VHRDBCACS2016-09-29
00811608013343HR Direct HighMag Vit (VHRDHMACS)VHRDHMACS2016-09-29
00811608013350HR Direct HM NSR Vit (VHRDHMNSRACS)VHRDHMNSRACS2016-09-29
00811608013183Flat SSV ACS (VFLATSSVACS)VFLATSSVACS2016-09-29
0081160801319015 Prism SSV ACS (VPRISMSSVACS)VPRISMSSVACS2016-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841668123942KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00841668144466KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00841668144473KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668123949KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144463KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144470KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00818806021774RxSight Contact LensRXSIGHT, INC.HJK2025-09-05
00811608014869Capsulotomy (VLUCAPS)VOLK OPTICAL INC.HJK2025-01-29
00811608015934Iridectomy (VLUIRID)VOLK OPTICAL INC.HJK2025-01-29
00856222004209SUPER VIEW Lens, Disposable Contact, TornambeOCULUS SURGICAL INCHJK2024-08-13
10856222004206SUPER VIEW Lens, Disposable Contact, TornambeOCULUS SURGICAL INCHJK2024-08-13
00811608014654Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
10811608014675Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
03760087122343SINGLE USE 3 MIRRORS CONTACT LENSFCI S A S FCI 20 22HJK2021-05-30
00852475007202"Contact Lens, HD Professional, Cohen-Benner, ""CBC"""OCULUS SURGICAL INCHJK2021-02-26
10852475007209Contact Lens, HD Professional, Cohen-Benner, "CBC"OCULUS SURGICAL INCHJK2021-02-26
00852475007042SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00852475007059SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00818806020531RxSight Contact LensRXSIGHT, INC.HJK2020-10-16
03760087122176Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122190Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122206Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122213Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123685Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123692Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123708Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122171Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122195Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122201Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122218Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06