FDA Registration
Active
🇺🇸 United States
Spherical
Reg #: 1065845
·
FEI: 3003040707
·
Expires 2025
Products
1
Proprietary Names
27
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
- K011914
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
Pinnacle
Proplus Bifocal
Arc-Seg
Summit
Limbal
Aspheric
Bi-Toric Summit
EZEyes
Flex 3
Ful-Vue
MVP
MegaThin
PostGraft
Read Rite Bifocal
Continu Vu
Post Lasik
American Standard
EasyFocus Plus
SCone
Bitoric
Ideal Cone
Infinity GP
TriCurve
Front Toric
QuadraCurve
ContinuVu Plus
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)