510(k) Report

FDA applicant

X-Cel Specialty Contacts, A Walman Optical Company

Duluth, GA1 decision2024–20240 recalls

FDA records 1 decision for X-Cel Specialty Contacts, A Walman Optical Company (Duluth, GA) in 2024: 1 510(k) clearance. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided X-Cel Specialty Contacts, A Walman Optical Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — X-Cel Specialty Contacts, A Walman Optical Company by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LPLLenses, Soft Contact, Daily Wear1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company · 2024

The one decision as X-Cel Specialty Contacts, A Walman Optical Company →