FDA Registration
Active
🇺🇸 United States
VOLK OPTICAL INC.
Reg #: 1528142
·
FEI: 1000122772
·
Expires 2026
Products
16
Proprietary Names
363
Establishment Types
3
Classifications
15
Registration Details
- Registration Name
- VOLK OPTICAL INC.
- Registration Number
- 1528142
- FEI Number
- 1000122772
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7893 ENTERPRISE DR.
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K023221
Owner / Operator
- Firm Name
- VOLK OPTICAL INC.
- Operator Number
- 9000705
- Address
- 7893 ENTERPRISE DR.
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
- Correspondent
- Peter Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stand, Instrument, Ophthalmic, Non-Powered | HMG | Class 1 | Ophthalmic | No | 2014-03-21 |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2015-09-18 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2019-02-27 |
| Microscope, Surgical, General & Plastic Surgery | FSO | Class 1 | General, Plastic Surgery | No | 2001-08-16 |
| Ophthalmoscope, Battery-Powered | HLJ | Class 2 | Ophthalmic | No | 2009-11-05 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2003-04-23 |
| Camera, Ophthalmic, General-Use | PJZ | Class 2 | Ophthalmic | No | 2015-09-23 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2020-11-23 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2009-11-05 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2009-11-05 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-02-20 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2007-03-08 |
| Prism, Gonioscopic | HKS | Class 1 | Ophthalmic | No | 2008-09-22 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2014-04-01 |
| NSX | No | 2016-04-12 | |||
| Lens, Condensing, Diagnostic | HJL | Class 1 | Ophthalmic | No | 2008-09-22 |
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)
90D Limited Edition #2 (V90C-LE2)
Super 66® Limited Edition #2 (VS66-LE2)
Pan Retinal 2.2 Clear (VPRC)
90D Clear, Gold Ring (V90C-GD)
78D Clear, Red Ring (V78C-RD)
V28D Large Clear, Purple Ring (V28LC-PE)
V28D Large Clear, Green Ring (V28LC-GN)
V20D Large Clear, Green Ring (V20LC-GN)
20D Large Clear (V20LC)
SuperPupil XL (VSPXL)
VPR2.2 Clear, Blue Ring (VPRC-BE)
SuperVitreo Fundus (VSVF)
V20D Large Clear, Silver Ring (V20LC-SR)
Digital High Mag, Gold (VDGTLHM-GD)
40D Large Clear (V40LC)
Digital Wide Field, Purple (VDGTLWF-PE)
20D ACS PermaView (V20LCACSPV)
Digital 1X Mag (VDGTL1)
Super66 Stereo Fundus (VS66)
Superfield NC, Gold Ring (VSFNC-GD)
Super66, Purple Ring (VS66-PE)
90D Clear, Red Ring (V90C-RD)
90D Clear, Green Ring (V90C-GN)
90D Clear, Silver Ring (V90C-SR)
28D Large Clear (V28LC)
V20D Large Clear, Gold Ring (V20LC-GD)
Superfield NC, Purple Ring (VSFNC-PE)
V28D Large Clear, Gold Ring (V28LC-GD)
Superfield NC (VSFNC)
Super66, Red Ring (VS66-RD)
Digital ClearField (VDGTLCF)
15D Large Clear (V15LC)
V20D Large Clear, Blue Ring (V20LC-BE)
78D Clear, Gold Ring (V78C-GD)
VPR2.2 Clear, Red Ring (VPRC-RD)
Digital High Mag (VDGTLHM)
Superfield NC, Blue Ring (VSFNC-BE)
Digital Wide Field (VDGTLWF)
VPR2.2 Clear, Gold Ring (VPRC-GD)
Superfield NC, Green Ring (VSFNC-GN)
V20D Large Clear, Purple Ring (V20LC-PE)
Digital High Mag, Silver (VDGTLHM-SR)
Digital High Mag, Black (VDGTLHM-BK)
Digital ClearField, Red Ring (VDGTLCF-RD)
Digital Wide Field, Black (VDGTLWF-BK)
Digital Wide Field, Gold (VDGTLWF-GD)
78D Clear, Purple Ring (V78C-PE)
Disposable 20LCD (V20LCD)
V28D Large Clear, Blue Ring (V28LC-BE)
30D Small Clear (V30SC)
90D Clear (V90C)
Digital High Mag, Red (VDGTLHM-RD)
30D Large Clear (V30LC)
78D Clear, Blue Ring (V78C-BE)
Digital Wide Field, Silver (VDGTLWF-SR)
28D ACS PermaView (V28LCACSPV)
V20D Large Clear, Red Ring (V20LC-RD)
Super66, Green Ring (VS66-GN)
Digital ClearField, Gold Ring (VDGTLCF-GD)
Digital Wide Field, Green (VDGTLWF-GN)
Digital ClearField, Green Ring (VDGTLCF-GN)
Macula Plus 5.5 (VMP5.5)
14D Large Clear (V14LC)
90D Clear, Blue Ring (V90C-BE)
V28D Large Clear, Silver Ring (V28LC-SR)
Superfield NC, Silver Ring (VSFNC-SR)
Digital ClearField, Silver Ring (VDGTLCF-SR)
Single Use 20D (V20LCD)
78D Clear, Silver Ring (V78C-SR)
VPR2.2 Clear, Green Ring (VPRC-GN)
Superfield NC, Red Ring (VSFNC-RD)
Digital ClearField, Black (VDGTLCF-BK)
Super66, Gold Ring (VS66-GD)
78D Clear, Green Ring (V78C-GN)
Digital ClearMag (VDGTLCM)
90D Clear, Purple Ring (V90C-PE)
V28D Large Clear, Red Ring (V28LC-RD)
VPR2.2 Clear, Purple Ring (VPRC-PE)
Super66, Blue Ring (VS66-BE)
Digital ClearField, Purple Ring (VDGTLCF-PE)
Super66, Silver Ring (VS66-SR)
Digital High Mag, Purple (VDGTLHM-PE)
78D Clear (V78C)
Digital High Mag, Green (VDGTLHM-GN)
60D Clear (V60C)
25D Large Clear (V25LC)
VPR2.2 Clear, Silver Ring (VPRC-SR)
Single Use 28D (V28LCD)
Digital Wide Field, Red (VDGTLWF-RD)
Disposable 28LCD (V28LCD)
Single Use 28D Box of 100 (V28LCD100)
Single Use 28D Box of 10 (V28LCD10)
Single Use 28D Box of 400 (V28LCD400)
Single Use 20D Box of 10 (V20LCD10)
Single Use 20D Box of 100 (V20LCD100)
Single Use 20D Box of 400 (V20LCD400)
V20D Large Clear, Custom Color (V20LC-CC)
V90D Clear, Custom Color (V90C-CC)
V78D Clear, Custom Color (V78C-CC)
Digital Wide Field, Custom Color (VDGTLWF-CC)
Superfield NC, Custom Color (VSFNC-CC)
SuperField® Limited Edition (VSFNC-LE)
20D Limited Edition (V20LC-LE)
Pan Retinal 2.2 Limited Edition (VPRC-LE)
78D Limited Edition #2 (V78C-LE2)
20D Limited Edition #2 (V20LC-LE2)
Digital Wide Field® Limited Edition #2 (VDGTLWF-LE2)
Super Field® Limited Edition #2 (VSFNC-LE2)
Pan Retinal 2.2 Limited Edition #2 (VPRC-LE2)
Digital ClearField Limited Edition (VDGTLCF-LE)
Super 66® Limited Edition (VS66-LE)
28D Limited Edition #2 (V28LC-LE2)
78D Limited Edition (V78C-LE)
90D Limited Edition (V90C-LE)
Digital High Mag Limited Edition (VDGTLHM-LE)
28D Limited Edition (V28LC-LE)
Digital Wide Field® Limited Edition (VDGTLWF-LE)
Disposable Direct Image WideField (VWFD)
Disposable Direct Image 1.5x Mag (VMD)
Disposable Direct Image 30 Prism (V30PD)
Disposable Direct Image BiConcave (VBCD)
Disposable Direct Image Flat (VFD)
Disposable Direct Image Flat SSV (VFLATSSVD)
Disposable Direct Image Flat Box of 10 (VFD10)
Disposable Direct Image 30 Prism Box of 100 (V30PD100)
Disposable Direct Image 30 Prism Box of 800 (V30PD800)
Disposable Direct Image BiConcave Box of 100 (VBCD100)
Disposable Direct Image 1.5x Mag Box of 100 (VMD100)
Disposable Direct Image WideField Box of 10 (VWFD10)
Disposable Direct Image WideField Box of 100 (VWFD100)
Disposable Direct Image 30 Prism Box of 10 (V30PD10)
Disposable Direct Image Flat Box of 800 (VFD800)
Disposable Direct Image WideField Box of 800 (VWFD800)
Disposable Direct Image Flat SSV Box of 10 (VFLATSSVD10)
Disposable Direct Image 1.5x Mag Box of 800 (VMD800)
Disposable Direct Image Flat SSV Box of 100 (VFLATSSVD100)
Disposable Direct Image BiConcave Box of 800 (VBCD800)
Disposable Direct Image Flat SSV Box of 800 (VFLATSSVD800)
Disposable Direct Image Flat Box of 100 (VFD100)
Disposable Direct Image 1.5x Mag Box of 10 (VMD10)
Disposable Direct Image BiConcave Box of 10 (VBCD10)
Single Use Indirect Wide Field Box of 400 (VVITSSVDH400)
Single Use Indirect Wide Field Box of 10 (VVITSSVDH10)
Single Use Indirect Wide Field Box of 100 (VVITSSVDH100)
Single Use Indirect Wide Field (VVITSSVDH)
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility