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
Lens, Contact (Other Material) - Daily HQD

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)