510(k) Report

FDA applicant

Starr Surgical Co.

Monrovia2 decisions2000–20015 recalls

FDA records 2 decisions for Starr Surgical Co. (Monrovia) from 2000 to 2001: 2 original PMA approvals. Most are in product codes HQL (Intraocular Lens) and OGO (Intraocular Pressure Lowering Implant). 5 recalls are 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 Starr Surgical Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Starr Surgical Co. since 2007.

Recalls per year

2in 2013

2011: 12013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Starr Surgical Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Starr”

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