FDA applicant

Biolitec Medical Devices, Inc.

Grandville, MA9 decisions2011–20120 recalls

FDA records 9 decisions for Biolitec Medical Devices, Inc. (Grandville, MA) from 2011 to 2012: 9 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 15 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, general and plastic surgery panel, where it files most

How often FDA has decided Biolitec Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

5in 2012

2011high 5 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

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

Planning a device like Biolitec Medical Devices, Inc.’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 “Biolitec”

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

Biolitec, Inc. 29 Biolitec Sia 1 Biolitec Sia (Latvia) 1

Biolitec Medical Devices, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Biolitec”