FDA Registration
Active
🇺🇸 United States
Mounting Kit, Topcon OMS-800 (12162)
Reg #: 1528142
·
FEI: 1000122772
·
Expires 2025
Products
1
Proprietary Names
58
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 |
|---|---|---|---|---|---|
| Microscope, Surgical, General & Plastic Surgery | FSO | Class 1 | General, Plastic Surgery | No | 2001-08-16 |
Proprietary Names
Mounting Kit, Topcon OMS-800 (12162)
Volk SOLR Condensing Lens 175 (VSOLRCL175)
ROLS - Leica / Wild Compatible - (VROLS-LX)
Merlin CLA - 200 Manual (11378)
ROLS+ - Leica / Wild Compatible - (VROLS-L+)
Merlin LPU 200 for CLA (11174)
Merlin CLA - 175 Auto (11375)
Merlin CLA - 200 Auto (11376)
ROLS - Zeiss Compatible - (VROLS-Z)
Merlin RA (11179)
Merlin LPU 175 for RA (11171)
Merlin LPU 200 for RA (11172)
ROLS - Leica / Wild Compatible - (VROLS-L)
Merlin LPU 175 for CLA (11173)
Merlin CLA - 175 Manual (11377)
ROLS Infinity, Zeiss - Auto (11363)
ROLS+ - Zeiss Compatible - (VROLS-Z+)
ROLS Infinity, Leica - Auto (11364)
Kit, Merlin RA Mount, Leica 690 (11411)
Kit, Merlin Mount, L 820/840/841/844 (12160)
ROLS Infinity, Leica - Manual (11315)
Kit, Merlin RA Mount, Zeiss MD (11552)
Kit, Merlin Mount, MW HS HiR (12161)
ROLS® Reinverter Leica+ (Open Flange) (VROLS-LX+)
Kit, Merlin Mount, Topcon (11413)
Kit, Merlin Mount, Topcon OMS90 (11947)
ASSY, Small Diameter Wide Angle NC Lens (11184)
Kit, Merlin CLA Mount Leica 690 (11481)
Kit, Merlin Mount, Zeiss Visu (12163)
ASSY, 175 mm Condensing Lens Replacement (11275)
ROLS Infinity, Zeiss - Manual (11313)
Kit, Merlin Mount, M-W (11410)
Kit, Merlin Mount, Spacing (11425)
ASSY, 200 mm Condensing Lens Replacement (11277)
Kit, Merlin Mount, Leica M690 (12159)
Kit, Merlin Mount, Zeiss (11408)
Kit, Merlin Mount Alcon (11732)
Kit, Merlin Mount, Leica (11409)
ASSY, Wide Angle NC Lens (11183)
Kit, Merlin Mount, Takagi (11412)
Kit, Merlin Mount, M822 (12171)
ASSY, Mid-Field NC Lens (11182)
Kit, Merlin CLA Mount, Zeiss MD (11553)
Kit, Merlin Mount, Inami (11654)
OptiFlex
Volk SOLR Lens Arm (VSOLRLA)
Volk SOLR Surgical System 175 (VSOLR175)
Volk SOLR Mid Field Lens (VSOLRMFL)
Mounting Kit, Takagi OM-9 (12645)
Volk SOLR Surgical System (VSOLR)
Mounting Kit, Alcon Revalia (12640)
Volk SOLR Wide Angle Lens (VSOLRWAL)
Mounting Kit, MediWorks SM621 (12655)
Volk SOLR Lens Arm 175 (VSOLRLA175)
Volk SOLR Condensing Lens (VSOLRCL)
Volk SOLR Small Wide Angle Lens (VSOLRSWAL)
Volk SOLR Rotation Base (VSOLRRB)
Mounting Kit, Takagi OM-19 (12650)
Establishment Types
Manufacture Medical Device