FDA Registration
Active
🇺🇸 United States
Spherical
Reg #: 1065845
·
FEI: 3003040707
·
Expires 2025
Products
1
Proprietary Names
28
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
- 510(k) Number
- K974636
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 (Other Material) - Daily | HQD | Class 2 | Ophthalmic | No | 2022-09-30 |
Proprietary Names
Spherical
Starlens
Arc-Seg
Bitoric
EasyFocus Plus
Read Rite Bifocal
SCone
American Standard
Flex 3
Proplus Bifocal
Pinnacle LD
Front Toric
Continu Vu
Aspheric
MVP
QuadraCurve
Pinnacle
Bi-Toric Summit
Infinity GP
MegaThin
TriCurve
PostGraft
Post Lasik
Apex
Limbal
Summit
EZEyes
ContinuVu Plus
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)