FDA Registration
Active
🇺🇸 United States
HRX SSV ACS (VHRXVITSSVACS)
Reg #: 1528142
·
FEI: 1000122772
·
Expires 2025
Products
1
Proprietary Names
13
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
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 |
|---|---|---|---|---|---|
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2015-09-18 |
Proprietary Names
HRX SSV ACS (VHRXVITSSVACS)
30 Prism SSV ACS (V30PRISMSSVACS)
Central Retinal ACS (VCRLVITACS)
45 Prism SSV ACS (V45PRISMSSVACS)
15 Prism SSV ACS (VPRISMSSVACS)
HRX ACS (VHRXVITACS)
Mid Field SSV ACS (VMFSSVACS)
High Mag SSV ACS (VFHMSSVACS)
MiniQuad ACS (VMQVITACS)
AFX SSV ACS (VAFXSSVACS)
MiniQuad SSV ACS (VMQVITSSVACS)
Flat SSV ACS (VFLATSSVACS)
Central Retinal SSV ACS (VCRLVITSSVACS)
Establishment Types
Manufacture Medical Device