Data / Medical devices / United States / X-Cel Specialty Contacts
X-Cel Specialty Contacts: FDA-registered device maker in Duluth, GA, United States, 17 510(k) clearances and 1 PMA approval
X-Cel Specialty Contacts is registered with the FDA (registration 1065845) in Duluth, GA, United States. It lists 6 device types. The FDA files 17 510(k) clearances and 1 PMA approval under its listings, the newest dated August 14, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1065845
- FEI number
- 3003040707
- Address
- 2775 Premiere Pkwy Ste 600, Duluth, GA, United States, 30097
- Owner or operator
- Walman Optical (2125182)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- November 15, 2007
- Registered through
- 2026
- Brand names listed
- American Standard, Apex, Apogee, Arc-Seg, Aspheric, Aspheric Periphery, Atlantis, Atlantis 3D and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact (Orthokeratology) | MUW | 2 | Contract manufacturer | accessdata.fda.gov |
| Lens, Contact (Other Material) - Daily | HQD | 2 | Contract manufacturer | accessdata.fda.gov |
| Lens, Contact (Polymethylmethacrylate) | HPX | U | Contract manufacturer | accessdata.fda.gov |
| Lens, Contact (Rigid Gas Permeable), Extended Wear | MWL | 3 | Contract manufacturer | accessdata.fda.gov |
| Lens, Contact, Orthokeratology, Overnight | NUU | 3 | Contract manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Contract manufacturer, Contract sterilizer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 14, 2024 | K242059 | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) | LPL | Substantially Equivalent | X-Cel Specialty Contacts, A Walman Optical Company | accessdata.fda.gov |
| October 28, 2010 | K100443 | DEFINITIVE, FLEXLENS - SILICONE HYDROGEL | LPL | Substantially Equivalent | X-Cel Contacts, Inc. | accessdata.fda.gov |
| April 22, 2008 | K080686 | WESTCON HORIZON 49% (HIOXIFILCON B) | LPL | Substantially Equivalent | Westcon Contact Lens Co. | accessdata.fda.gov |
| March 12, 2007 | K070308 | FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR | LPL | Substantially Equivalent | X-Cel Contacts | accessdata.fda.gov |
| February 1, 2005 | K043540 | HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES | LPL | Substantially Equivalent | Westcon Contact Lens Co., Inc. | accessdata.fda.gov |
| February 20, 2004 | K031774 | HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES | LPL | Substantially Equivalent | Westcon Contact Lens Co., Inc. | accessdata.fda.gov |
| May 30, 2003 | K030593 | FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC | LPL | Substantially Equivalent | X-Cel Contacts, A Walman Co. | accessdata.fda.gov |
| November 26, 2002 | K023530 | HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) | LPL | Substantially Equivalent | Westcon Contact Lens Co., Inc. | accessdata.fda.gov |
| June 29, 1999 | K992010 | W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) | LPL | Substantially Equivalent | Westcon Contact Lens Co., Inc. | accessdata.fda.gov |
| December 20, 1996 | K963837 | HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN | LPL | Substantially Equivalent | Westcon Contact Lens Co., Inc. | accessdata.fda.gov |
| October 1, 1996 | K962000 | FLEXLENS(METHAFILCON A) | LPL | Substantially Equivalent | Flexlens, Inc. | accessdata.fda.gov |
| October 1, 1996 | K961943 | FLEXLENS | LPL | Substantially Equivalent | Flexlens, Inc. | accessdata.fda.gov |
| August 26, 1996 | K962121 | HORIZON/WESTHIN 55-G | LPL | Substantially Equivalent | Westcon Contact Lens Co., Inc. | accessdata.fda.gov |
| April 11, 1996 | K950294 | FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | Flexlens, Inc. | accessdata.fda.gov |
| March 28, 1996 | K954524 | W-55 (METHAFILON A) CONTACT LENS | LPL | Substantially Equivalent | Westcon Contact Lens Co., Inc. | accessdata.fda.gov |
| March 21, 1995 | K950818 | HORIZON 55 BI-CON TORIC | LPL | Substantially Equivalent | Westcon Contact Lens Co., Inc. | accessdata.fda.gov |
| December 28, 1994 | K945365 | HORIZON 55 BI-CON | LPL | Substantially Equivalent | Westcon Contact Lens Co., Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 9, 1987 | P830012 | SOFTICS(TM) (POLYMACON) | LPL | 3 | June 25, 1990 | accessdata.fda.gov |
Compare with other makers
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact (Other Material) - Daily
- All makers of Lens, Contact, Orthokeratology, Overnight
- All makers of Lens, Contact (Rigid Gas Permeable), Extended Wear
- All makers of Lens, Contact (Orthokeratology)
- All makers of Lens, Contact (Polymethylmethacrylate)
Updated August 14, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.