FDA Registration
Active
🇺🇸 United States
90D Limited Edition (V90C-LE)
Reg #: 1528142
·
FEI: 1000122772
·
Expires 2025
Products
1
Proprietary Names
109
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VOLK OPTICAL INC.
- Registration Number
- 1528142
- FEI Number
- 1000122772
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7893 ENTERPRISE DR.
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
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 |
|---|---|---|---|---|---|
| Lens, Condensing, Diagnostic | HJL | Class 1 | Ophthalmic | No | 2008-09-22 |
Proprietary Names
90D Limited Edition (V90C-LE)
20D Limited Edition (V20LC-LE)
Digital High Mag, Red (VDGTLHM-RD)
30D Large Clear (V30LC)
90D Clear, Silver Ring (V90C-SR)
Macula Plus 5.5 (VMP5.5)
V20D Large Clear, Green Ring (V20LC-GN)
SuperVitreo Fundus (VSVF)
V28D Large Clear, Silver Ring (V28LC-SR)
Digital High Mag (VDGTLHM)
V20D Large Clear, Purple Ring (V20LC-PE)
ACS 28LC PermaView (V28LCACSPV)
Digital ClearField, Black (VDGTLCF-BK)
30D Small Clear (V30SC)
V20D Large Clear, Silver Ring (V20LC-SR)
90D Clear (V90C)
78D Clear, Red Ring (V78C-RD)
Super66, Purple Ring (VS66-PE)
VPR2.2 Clear, Green Ring (VPRC-GN)
90D Clear, Gold Ring (V90C-GD)
Digital High Mag, Black (VDGTLHM-BK)
90D Clear, Green Ring (V90C-GN)
Digital Wide Field, Black (VDGTLWF-BK)
Superfield NC, Gold Ring (VSFNC-GD)
90D Clear, Blue Ring (V90C-BE)
Digital ClearField, Purple Ring (VDGTLCF-PE)
78D Clear, Purple Ring (V78C-PE)
Digital ClearField, Red Ring (VDGTLCF-RD)
VPR2.2 Clear, Blue Ring (VPRC-BE)
20D Large Clear (V20LC)
60D Clear (V60C)
Superfield NC, Red Ring (VSFNC-RD)
Single Use 28D (V28LCD)
V28D Large Clear, Purple Ring (V28LC-PE)
14D Large Clear (V14LC)
Disposable 28LCD (V28LCD)
Digital Wide Field, Purple (VDGTLWF-PE)
VPR2.2 Clear, Gold Ring (VPRC-GD)
Superfield NC, Green Ring (VSFNC-GN)
78D Clear (V78C)
Digital Wide Field, Red (VDGTLWF-RD)
V20D Large Clear, Gold Ring (V20LC-GD)
SuperPupil XL (VSPXL)
V28D Large Clear, Gold Ring (V28LC-GD)
Superfield NC, Blue Ring (VSFNC-BE)
Digital Wide Field (VDGTLWF)
90D Clear, Purple Ring (V90C-PE)
78D Clear, Blue Ring (V78C-BE)
Digital Wide Field, Gold (VDGTLWF-GD)
Superfield NC, Silver Ring (VSFNC-SR)
V28D Large Clear, Blue Ring (V28LC-BE)
Digital ClearField, Gold Ring (VDGTLCF-GD)
40D Large Clear (V40LC)
Digital Wide Field, Silver (VDGTLWF-SR)
Digital Wide Field, Green (VDGTLWF-GN)
Digital ClearField, Green Ring (VDGTLCF-GN)
78D Clear, Silver Ring (V78C-SR)
25D Large Clear (V25LC)
VPR2.2 Clear, Silver Ring (VPRC-SR)
Super66, Red Ring (VS66-RD)
Digital High Mag, Gold (VDGTLHM-GD)
V20D Large Clear, Red Ring (V20LC-RD)
78D Clear, Green Ring (V78C-GN)
Super66 Stereo Fundus (VS66)
Digital ClearMag (VDGTLCM)
Digital ClearField, Silver Ring (VDGTLCF-SR)
V28D Large Clear, Red Ring (V28LC-RD)
VPR2.2 Clear, Purple Ring (VPRC-PE)
Super66, Blue Ring (VS66-BE)
Super66, Silver Ring (VS66-SR)
Digital High Mag, Purple (VDGTLHM-PE)
28D Large Clear (V28LC)
Superfield NC, Purple Ring (VSFNC-PE)
Digital High Mag, Silver (VDGTLHM-SR)
90D Clear, Red Ring (V90C-RD)
Superfield NC (VSFNC)
Digital High Mag, Green (VDGTLHM-GN)
Digital ClearField (VDGTLCF)
V28D Large Clear, Green Ring (V28LC-GN)
Super66, Green Ring (VS66-GN)
Super66, Gold Ring (VS66-GD)
ACS 20LC PermaView (V20LCACSPV)
Digital 1X Mag (VDGTL1)
15D Large Clear (V15LC)
Pan Retinal 2.2 Clear (VPRC)
78D Clear, Gold Ring (V78C-GD)
VPR2.2 Clear, Red Ring (VPRC-RD)
Disposable 20LCD (V20LCD)
Single Use 20D (V20LCD)
Single Use 20D Box of 10 (V20LCD10)
V20D Large Clear, Blue Ring (V20LC-BE)
Single Use 20D Box of 100 (V20LCD100)
Single Use 20D Box of 400 (V20LCD400)
Single Use 28D Box of 10 (V28LCD10)
V90D Clear, Custom Color (V90C-CC)
Single Use 28D Box of 100 (V28LCD100)
Single Use 28D Box of 400 (V28LCD400)
V78D Clear, Custom Color (V78C-CC)
V20D Large Clear, Custom Color (V20LC-CC)
Superfield NC, Custom Color (VSFNC-CC)
Digital Wide Field, Custom Color (VDGTLWF-CC)
Super 66® Limited Edition (VS66-LE)
Pan Retinal 2.2 Limited Edition (VPRC-LE)
Digital High Mag® Limited Edition (VDGTLHM-LE)
28D Limited Edition (V28LC-LE)
Digital Wide Field® Limited Edition (VDGTLWF-LE)
SuperField® Limited Edition (VSFNC-LE)
78D Limited Edition (V78C-LE)
Digital ClearField Limited Edition (VDGTLCF-LE)
Establishment Types
Manufacture Medical Device