Home›USA›Volk Optical, Inc.

Volk Optical, Inc.

USA · Mentor

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 10Class II 5Class III 0unclassified 1

plus 22 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 5

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class II 3

14 including historic records

TWTaiwanTFDA

4valid device licences

Class I 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 3IIa 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States22 registration records, 4 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: VOLK OPTICAL INC. · VOLK OPTICAL, INC

FDA 510(k) clearances by year

11994 · K943125

12002 · K023221

12005 · K050623

12015 · K151961

FDA listed device types

showing 8 of 16

Ring, Ophthalmic (Flieringa) 1Stand, Instrument, Ophthalmic, Non-Powered 1Lens, Condensing, Diagnostic 1Light, Examination, Medical, Battery Powered 1Device, Irrigation, Ocular Surgery 1Forceps, Ophthalmic 1Prism, Gonioscopic 1Otoscope 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K151961	Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens	2015-08-18
US	K050623	VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D	2005-03-28
US	K023221	CONTACT LASER & DIAGNOSTIC LENSES	2002-10-11
BR	81346500087	Lentes Volk (Reutilizáveis)	Class I
BR	81346500088	Lentes Volk (Uso Único)	Class I
BR	81346500089	Sistemas Cirúrgicos Volk	Class I
SA	ME0000008471SFDAA00018	VOLK VistaView	—
SA	ME0000008471SFDAA00021	Volk Pictor Prestige	—
CA	2941	VOLK CONTACT ADAPTERS	Class II
CA	2942	VOLK DIRECT VIEW LENSES	Class II
CA	96334	VOLK INVIEW	Class II

Volk Optical, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies