Contract manufacturerContract sterilizerX-CEL SPECIALTY CONTACTS (Duluth, GA)GeorgiaOphthalmicUnclassifiedClass IIClass III
X-CEL SPECIALTY CONTACTS
Contract manufacturer and sterilizer ยท Duluth, GA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1065845 (openFDA record; or search FDA's registration database)
- FEI number
- 3003040707
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Contract sterilizer
- Owner or operator
- Walman Optical (FDA owner/operator no. 2125182)
- Registered address
- 2775 Premiere Pkwy Ste 600, Duluth, GA 30097
- Contract listings
- 27 device listings, 6 product codes, first listed Nov 19, 2007
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| HPX | Lens, Contact (Polymethylmethacrylate) | Unclassified | Ophthalmic | Contract manufacturing | Dec 11, 2023 |
| HQD | Lens, Contact (Other Material) - Daily | Class II | Ophthalmic | Contract manufacturing | Nov 19, 2007 |
| LPL | Lenses, Soft Contact, Daily Wear | Class II | Ophthalmic | Contract manufacturing | Feb 12, 2025 |
| LPL | Lenses, Soft Contact, Daily Wear | Class II | Ophthalmic | Contract sterilization | Feb 12, 2025 |
| MUW | Lens, Contact (Orthokeratology) | Class II | Ophthalmic | Contract manufacturing | Dec 19, 2022 |
| MWL | Lens, Contact (Rigid Gas Permeable), Extended Wear | Class III | Ophthalmic | Contract manufacturing | Jul 14, 2022 |
| NUU | Lens, Contact, Orthokeratology, Overnight | Class III | Ophthalmic | Contract manufacturing | Jul 14, 2022 |