FDA applicant
Mnlase, Inc.
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
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.
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.
See the 510(k) Report