FDA Registration
Active
🇺🇸 United States
Westcon Horizon Progressive Toric
Reg #: 1065845
·
FEI: 3003040707
·
Expires 2025
Products
1
Proprietary Names
21
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
- K992010
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 |
|---|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2008-12-02 |
Proprietary Names
Westcon Horizon Progressive Toric
Westcon Horizon Prism Sphere
Westcon Westhin Toric
Flexlens Piggyback
Westcon Horizon Toric
Flexlens Prism Sphere
Flexlens Multifocal
Westcon Horizon Bi-Con
Westcon Horizon Progressive
Westcon Horizon Sphere
Flexlens Sphere
Westcon Horizon Bi-Con Toric
Westcon Horizon Large Diameter
Flexlens Toric
Flexlens Keratoconus
Flexlens Adult Aphakic
Westcon Horizon Aphakic
Westcon Horizon Adult Aphakic
Flexlens Aphakic
Flexlens Tricurve Keratoconus
Flexlens PRS
Establishment Types
Manufacture Medical Device