FDA Registration
Active
🇺🇸 United States
Arc-Seg
Reg #: 1065845
·
FEI: 3003040707
·
Expires 2025
Products
1
Proprietary Names
29
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
- K180616
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 | 2022-12-19 |
Proprietary Names
Arc-Seg
Reverse Geometry Sphere
EZEyes
Flex 3
QuadraCurve
Proplus Bifocal
SCone
Pinnacle
American Standard
Continu Vu
TriCurve
Bi-Toric Summit
ContinuVu Plus
Limbal
Pinnacle IC
Starlens
PostGraft
Bitoric
Spherical
Front Toric
Read Rite Bifocal
Titan LD
Pinnacle LD
MegaThin
Summit
MVP
Aspheric
Post Lasik
EasyFocus Plus
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)