FDA applicant

Opto Electronica SA

Sao Carlos, Sao Paulo, BR1 decision2011–20110 recalls

FDA records 1 decision for Opto Electronica SA (Sao Carlos, Sao Paulo, BR) in 2011: 1 510(k) clearance. All are in product code HQF (Laser, Ophthalmic). 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 Opto Electronica SA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Opto Electronica SA by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Opto Electronica SA’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 “Opto”

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

Opto Vision, Inc. 2 Opto Global, Inc. 1 Opto Eletronica S/A 1

Opto Electronica SA

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Opto”