510(k) Report

FDA applicant

Medical Energy, Inc.

Pensacola, FL7 decisions1987–20040 recalls

FDA records 7 decisions for Medical Energy, Inc. (Pensacola, FL) from 1987 to 2004: 7 510(k) clearances. Most are in product codes LNK (Laser For Gastro-Urology Use) and 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 Medical Energy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Energy, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Energy, 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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