FDA Registration
Active
🇺🇸 United States
Reverse Geometry
Reg #: 1065845
·
FEI: 3003040707
·
Expires 2025
Products
1
Proprietary Names
37
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- X-CEL SPECIALTY CONTACTS
- Registration Number
- 1065845
- FEI Number
- 3003040707
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2775 Premiere Pkwy Ste 600
- City
- DULUTH
- State
- GA
- ZIP
- 30097
- Country
- US
Regulatory Submissions
- PMA Number
- P820063
Owner / Operator
- Firm Name
- Walman Optical
- Operator Number
- 2125182
- Address
- 2775 Premiere Parkway Ste 600
- City
- Duluth
- State
- GA
- Postal Code
- 30097
- Country
- US
- Correspondent
- Hue N Tang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lens, Contact (Polymethylmethacrylate) | HPX | Class U | Unknown | No | 2023-12-11 |
Proprietary Names
Reverse Geometry
MVP
QuadraCurve
Continu Vu
TriCurve
Flex 3
Bi-Toric Summit
X-Cel Cone
American Standard
Visions
Pinnacle IC
Visions Custom
Proplus Bifocal
Summit
Front Toric
Starlens
Bitoric
PostGraft
EZEyes
Aspheric Periphery
Infinity GP
EasyFocus Plus
Limbal
Pinnacle
CV-4
Pinnacle LD
Read Rite Bifocal
Titan LD
Apex
Post Lasik
Spherical
ContinuVu Plus
SCone
Arc-Seg
Solution Bifocal
MegaThin
Aspheric
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)