FDA Registration
Active
🇺🇸 United States
ProPlus Bifocal
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
- K000133
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 | 2016-07-26 |
Proprietary Names
ProPlus Bifocal
Jupiter Plus
Arc-Seg
Aspheric
MVP
MegaThin
TriCurve
EZEyes
Bi-Toric Summit
Continu Vu
Read Rite Bifocal
Summit
ePerimeter
ContinuVu Plus
ProLook
Limbal
QuadraCurve
Flex 3
Front Toric
eJupiter
American Standard
EasyFocus Plus
Post Lasik
SCone
Spherical
Bitoric
PostGraft
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)