FDA applicant

Intra-Optics Labs. C/O Newman Assoc.

Laguna Hills, CA1 decision1986–19860 recalls

FDA records 1 decision for Intra-Optics Labs. C/O Newman Assoc. (Laguna Hills, CA) in 1986: 1 510(k) clearance. All are in product code HQE (Instrument, Vitreous Aspiration And Cutting…). 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 Intra-Optics Labs. C/O Newman Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intra-Optics Labs. C/O Newman Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Intra-Optics Labs. C/O Newman Assoc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intra-Optics Labs. C/O Newman Assoc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Intra-Optics”

FDA records each applicant name separately; these may or may not be the same firm.

Intra Luminal Therapeutics, Inc. 20 Intra-Lock International 13 Intra Lase Corp. 9 Intra Vantage, Inc. 1 Intra Special Catheters GmbH 1 Intra-Sonix, Inc. 1

Intra-Optics Labs. C/O Newman Assoc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Intra-Optics”