FDA Registration
Active
🇺🇸 United States
X-Cel Cone
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
- K201194
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 | 2022-12-06 |
Proprietary Names
X-Cel Cone
PostGraft
Wave
Spherical
Read Rite Bifocal
ePerimeter
MegaThin
Arc-Seg
EasyFocus Plus
eJupiter
EZEyes
Jupiter Plus
ProLook
Bitoric
Flex 3
TriCurve
MVP
Aspheric
Post Lasik
Front Toric
ContinuVu Plus
Limbal
Continu Vu
American Standard
SCone
Summit
QuadraCurve
Bi-Toric Summit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)