VOLK OPTICAL INC.

FDA Device Registration & Listing · Mentor, OH, US · Registration 1528142

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1528142
FEI Number
1000122772
Entity Name
VOLK OPTICAL INC.
City/State/Country
Mentor, OH, US
Establishment Address
7893 ENTERPRISE DR., Mentor, OH 44060, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
VOLK OPTICAL INC. (Owner Number: 9000705)
Owner / Operator Contact Address
7893 ENTERPRISE DR., Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Pictor Plus Slit Lamp Mount (VP2SLM) Pictor Slit Lamp Mount (VPSLM) Steady Mount (VSM) Pictor Prestige Slit Lamp Mount (VPPSLM) VistaView Slit Lamp Adapter (VVISTAVIEW2SLA) Central Retinal SSV ACS (VCRLVITSSVACS) Flat SSV ACS (VFLATSSVACS) 30 Prism SSV ACS (V30PRISMSSVACS) AFX SSV ACS (VAFXSSVACS) 45 Prism SSV ACS (V45PRISMSSVACS) Mid Field SSV ACS (VMFSSVACS) 15 Prism SSV ACS (VPRISMSSVACS) Central Retinal ACS (VCRLVITACS) HRX SSV ACS (VHRXVITSSVACS) MiniQuad ACS (VMQVITACS) High Mag SSV ACS (VFHMSSVACS) MiniQuad SSV ACS (VMQVITSSVACS) HRX ACS (VHRXVITACS) ROLS Adapter Kit, for Kaps (12269) ROLS+ - Zeiss Compatible - (VROLS-Z+) ROLS+ - Leica / Wild Compatible - (VROLS-L+) ROLS - Leica / Wild Compatible - (VROLS-LX) Merlin CLA - 175 Manual (11377) Merlin LPU 175 for RA (11171) Merlin RA (11179) Merlin LPU 200 for CLA (11174) Merlin LPU 175 for CLA (11173) ROLS - Zeiss Compatible - (VROLS-Z) Merlin CLA - 200 Manual (11378) Merlin CLA - 200 Auto (11376) ROLS - Leica / Wild Compatible - (VROLS-L) Merlin CLA - 175 Auto (11375) Merlin LPU 200 for RA (11172) ROLS Infinity, Leica - Auto (11364) Kit, Merlin Mount, Spacing (11425) Kit, Merlin Mount, Zeiss (11408) ROLS Infinity, Zeiss - Manual (11313) ASSY, Mid-Field NC Lens (11182) Kit, Merlin Mount, Inami (11654) ROLS Infinity, Zeiss - Auto (11363) ROLS Infinity, Leica - Manual (11315) ASSY, Small Diameter Wide Angle NC Lens (11184) Kit, Merlin Mount, Topcon OMS90 (11947) ASSY, 175 mm Condensing Lens Replacement (11275) Kit, Merlin Mount, Leica M690 (12159) Kit, Merlin Mount, Takagi (11412) Kit, Merlin Mount, Zeiss Visu (12163) Kit, Merlin Mount, M822 (12171) Kit, Merlin Mount, MW HS HiR (12161) Kit, Merlin Mount, M-W (11410) ASSY, 200 mm Condensing Lens Replacement (11277) Kit, Merlin Mount, L 820/840/841/844 (12160) ASSY, Wide Angle NC Lens (11183) Kit, Merlin Mount Alcon (11732) Kit, Merlin CLA Mount Leica 690 (11481) Kit, Merlin Mount, Topcon (11413) Kit, Merlin RA Mount, Zeiss MD (11552) Kit, Merlin RA Mount, Leica 690 (11411) Kit, Merlin CLA Mount, Zeiss MD (11553) Kit, Merlin Mount, Leica (11409) ROLS® Reinverter– Leica+ (Open Flange) (VROLS-LX+) OptiFlex Mounting Kit, Alcon Revalia (12640) Volk SOLR Surgical System 175 (VSOLR175) Volk SOLR Small Wide Angle Lens (VSOLRSWAL) Mounting Kit, MediWorks SM621 (12655) Mounting Kit, Takagi OM-19 (12650) Mounting Kit, Topcon OMS-800 (12162) Mounting Kit, Takagi OM-9 (12645) Mounting Kit, for Kaps SOM62 (12172) Volk SOLR Rotation Base (VSOLRRB) Volk SOLR Lens Arm (VSOLRLA) Volk SOLR Condensing Lens (VSOLRCL) Volk SOLR Condensing Lens 175 (VSOLRCL175) Volk SOLR Surgical System (VSOLR) Volk SOLR Lens Arm 175 (VSOLRLA175) Volk SOLR Wide Angle Lens (VSOLRWAL) Volk SOLR Mid Field Lens (VSOLRMFL) Ophthalmoscope - ri mini Ophthalmoscope L2 Standard Suture Ring 2 Posts (VSRS2) Disposable Capsulotomy (VCAPSD) Disposable Iridotomy (VIRIDD) Disposable Iridotomy Box of 400 (VIRIDD400) Disposable Iridotomy Box of 100 (VIRIDD100) Disposable Iridotomy Box of 10 (VIRIDD10) Disposable Capsulotomy Box of 10 (VCAPSD10) Disposable Capsulotomy Box of 100 (VCAPSD100) Disposable Capsulotomy Box of 400 (VCAPSD400) iNview for iPhone 5s (VINVIEW-5S) iNview for iPhone 6 (VINVIEW-6) iNview for iPod Touch (VINVIEW-TCH) iNview Touch Camera (VINVIEWC-TCH) VistaView (VVISTAVIEW) VistaView (VVISTAVIEW2) Viva (VVIVA1B) Viva (VVIVA1A) Volk Pictor Plus VP2HAND and VP2FA Pictor Prestige (VPPHAND, VPPANT, and VPPRET) Volk Pictor VP1Handset, VP1RET and VP1ANT Volk Pictor Plus VP2HAND, VP2RET and VP2ANT Volk Pictor Plus VP2HAND and VP1OTO Pictor VP1HAND and VP1OTO Volk Pictor Plus VP2HAND and VP1DERM RI-LIGHT; Fortelux H; FORTELUX N; ri-focus; ri-special VP1HAND and VP1DERM Area Centralis ANF+ (VACANF+) Mag Plus Iridectomy (VMPIRID) SuperMacula VIT (VSMACVIT) Super Macula 2.2 (VSMAC2.2) TransEquator NF (VTENF) HR Wide Field (VHRWF) Central Retinal Vit (VCRLVIT) QuadrAspheric ANF+ (VQFLANF+) Dynaview 156 VIT (VDVVIT) Central Retinal Vit SSV (VCRLVITSSV) Fundus Laser (VFUNDUS) HRX Vit (VHRXVIT) Quad Pediatric (VQPED) Mini Quad XL VIT (VMQXLVIT) QuadrAspheric (VQFL) Super Quad 160 (VSQUAD160) HR Direct 1X NSR Vit (VHRD1XNSRACS) Mini Quad Vit SSV (VMQVITSSV) Centralis Direct ANF+ (VCDANF+) Centralis Direct (VCD) QuadrAspheric NF (VQFLNF) HR Direct 1X Vit (VHRD1XACS) Idrees MidVitreous (VIMV) Fundus 20mm Laser (VFUNDUS20) Equator Plus ANF+ (VEPANF+) HR Centralis (VHRC) Super Quad 160 NF (VSQUAD160NF) Equator Plus NF (VEPNF) HR Direct Bi-Concave (VHRDBCACS) Area Centralis (VAC) HRX Vit SSV (VHRXVITSSV) TransEquator (VTE) PDT Laser (VPDT) Capsulotomy (VCAPS) Mini Quad VIT (VMQVIT) HR Direct HM NSR Vit (VHRDHMNSRACS) HR Direct HighMag Vit (VHRDHMACS) Iridectomy (VIRID) TransEquator ANF+ (VTEANF+) Mini Quad XL VIT SSV (VMQXLVITSSV) HR Direct Prism Vit (VHRD20PACS) Area Centralis NF (VACNF) Blumenthal SutureLysis (VBSL) Blumenthal Iridotomy (VBIRID) Singh MidVitreous (VSMV) Vitreo Lens Handle - Long (VVITHAN-LG) Vitreo Lens Handle for MQXL (VVITHAN-MQXL) Single Use GonioPro Surgical Lens + Multi-Port Stabilizer, Box of 800 (VSGLSBD800) Single Use GonioPro Surgical Multi-Port Stabilizer, Box of 10 (VSGSBD10) Single Use GonioPro Surgical Lens + Handle, Box of 400 (VSGLHD400) Single Use GonioPro Surgical Lens + Multi-Port Stabilizer, Box of 10 (VSGLSBD10) Single Use GonioPro Surgical Lens + Single-Port Stabilizer, Box of 800 (VSGLSAD800) Single Use GonioPro Surgical Single-Port Stabilizer, Box of 800 (VSGSAD800) Single Use GonioPro Surgical Lens + Handle, Box of 10 (VSGLHD10) Single Use GonioPro Surgical Lens + Single-Port Stabilizer, Box of 10 (VSGLSAD10) Single Use GonioPro Surgical Lens + Single-Port Stabilizer, Box of 100 (VSGLSAD100) Single Use GonioPro Surgical Lens Sample Box (VSGSAMPLEBOX) GonioPro Surgical Lens + Handle (VSGLHACS) Single Use GonioPro Surgical Multi-Port Stabilizer, Box of 100 (VSGSBD100) Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD) Single Use GonioPro Surgical Single-Port Stabilizer (VSGSAD) G-6 NF 2in1 Handle (VG6HAN2) G-4 Goniolaser Flange (VG4) Uncoated 3MirrorANF+ (VU3MIRANF+) G-4 HighMag Small Ring NF (VG4HMSNF) Surgical Goniotomy (VSGACS) G-1 Trabeculum Flange (VG1) 3 Mirror ANF+ (V3MIRANF+) 3 Mirror No Flange (V3MIR) G-6 Mirror NF Large Ring (VG6LNF) G-3 Goniofundus-Mini NF (VG3MININF) G-4 Mirror NF Small Ring (VG4SNF) G-3 Goniofundus NF (VG3NF) G-3 Goniofundus Flange (VG3) G-4 Mirror NF Large Ring (VG4LNF) G-4 HighMag 2in1 Handle NF (VG4HMHAN2) G-1 Trabeculum NF (VG1NF) Mini 4 Mirror ANF+ (V4MANF+) SLT (VSLT) G-4 NF 2in1 Handle (VG4HAN2) G-4 HighMag Flange (VG4HM) G-2 Trabeculum Flange (VG2) G-4 HighMag Large Ring NF (VG4HMLNF) Transcend TVG Surgical Gonio (VTSTVG) G-2 Trabeculum NF (VG2NF) Disposable 3-Mirror (V3MIRD) Disposable SLT (VSLTD) Disposable SLT Box of 10 (VSLTD10) Uncoated 3 MirrorNF (VU3MIR) Rapid SLT (VMSLT) Disposable 3-Mirror Box of 100 (V3MIRD100) Disposable SLT Box of 100 (VSLTD100) Disposable 4-Mirror (V4MIRD) Disposable SLT Box of 400 (VSLTD400) Disposable 3-Mirror Box of 10 (V3MIRD10) Disposable 4-Mirror box of 10 (V4MIRD10) Disposable 3-Mirror Box of 400 (V3MIRD400) Disposable 4-Mirror box of 100 (V4MIRD100) Disposable 4-Mirror box of 400 (V4MIRD400) Volk Vold Surgical Gonio Lens (VTSVVG) Single Use GonioPro Surgical Lens + Multi-Port Stabilizer, Box of 100 (VSGLSBD100) Single Use GonioPro Surgical Single-Port Stabilizer, Box of 100 (VSGSAD100) Single Use GonioPro Surgical Lens + Handle (VSGLHD) Single Use GonioPro Surgical Single-Port Stabilizer, Box of 10 (VSGSAD10) Single Use GonioPro Surgical Multi-Port Stabilizer, Box of 800 (VSGSBD800) Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD) Single Use GonioPro Surgical Lens + Handle, Box of 100 (VSGLHD100) Single Use GonioPro Surgical Lens + Single-Port Stabilizer (VSGLSAD) Infusion Handle (VINFHAN) Pictor Workstation (VPWSTNL) Pictor Worstation Pro (VPWSTNP)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HMG Stand, Instrument, Ophthalmic, Non-Powered Ophthalmic Class 1 886.1860 2014-03-21
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic Ophthalmic Class 2 886.1385 2015-09-18
OUG Medical Device Data System General Hospital Class 1 880.6310 2019-02-27
FSO Microscope, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4700 2001-08-16
HLJ Ophthalmoscope, Battery-Powered Ophthalmic Class 2 886.1570 2009-11-05
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2003-04-23
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic Ophthalmic Class 2 886.1385 2015-09-18
PJZ Camera, Ophthalmic, General-Use Ophthalmic Class 2 886.1120 2015-09-23
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2020-11-23
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2020-01-03
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2011-06-08
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2013-12-30
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2009-11-05
KYT Light, Examination, Medical, Battery Powered General Hospital Class 1 880.6350 2009-11-05
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-02-20
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic Ophthalmic Class 2 886.1385 2007-11-01
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2007-03-08
HKS Prism, Gonioscopic Ophthalmic Class 1 886.1660 2008-09-22
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2014-04-01
NSX N/A N/A Class N/A N/A 2016-04-12

Official Correspondent

Peter Chen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VOLK OPTICAL INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K041546 Canon, Inc. DIGITAL FUNDUS CAMERA, MODEL CF-60DSI 2004-06-23
K932506 Rudolf Riester GmbH & Co. KG RI-SCOPE (S) 1993-10-08
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2018 Optovue, Inc. 2
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1528142. Last updated year: 2026. Please use registration number 1528142 when referencing this establishment in official correspondence.
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