FDA applicant

Sheaumann Lasers

Oviedo, FL2 decisions2011–20110 recalls

FDA records 2 decisions for Sheaumann Lasers (Oviedo, FL) in 2011: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 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, general and plastic surgery panel, where it files most

How often FDA has decided Sheaumann Lasers’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

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

Planning a device like Sheaumann Lasers’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 “Sheaumann”

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

Sheaumann Laser, Inc. 2

Sheaumann Lasers

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sheaumann”