510(k) Report

FDA applicant

Saint John'S Plaza Medical Group

Santa Monica, CA1 decision1996–19960 recalls

FDA records 1 decision for Saint John'S Plaza Medical Group (Santa Monica, CA) in 1996: 1 510(k) clearance. All are in product code HQC (Unit, Phacofragmentation). 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 Saint John'S Plaza Medical Group’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Saint John'S Plaza Medical Group since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Saint John'S Plaza Medical Group 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?

  • HQCUnit, Phacofragmentation1decision

What has FDA decided for it lately?

  • K960811PhacoscopeSaint John'S Plaza Medical Group · 1996

The one decision as Saint John'S Plaza Medical Group →