510(k) Report

FDA applicant

Xavier A. Guerra, Ocularist, Inc.

San Antonio, TX2 decisions1997–19970 recalls

FDA records 2 decisions for Xavier A. Guerra, Ocularist, Inc. (San Antonio, TX) in 1997: 2 510(k) clearances. Most are in product codes HQT (Shell, Scleral) and HQN (Conformer, Ophthalmic). 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 Xavier A. Guerra, Ocularist, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Xavier A. Guerra, Ocularist, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Xavier A. Guerra, Ocularist, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HQTShell, Scleral1decision
  • HQNConformer, Ophthalmic1decision

What has FDA decided for it lately?

  • K970320Scleral ShellXavier A. Guerra, Ocularist, Inc. · 1997
  • K970319Ocular ConformerXavier A. Guerra, Ocularist, Inc. · 1997

All 2 as Xavier A. Guerra, Ocularist, Inc. →