510(k) Report

FDA applicant

Mnlase, Inc.

Reston, VA22 decisions1992–19940 recalls

FDA records 22 decisions for Mnlase, Inc. (Reston, VA) from 1992 to 1994: 22 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and JRM (Freezer). 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 Mnlase, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mnlase, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mnlase, 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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