510(k) Report

FDA applicant

Primary Technology, LLC

Tampa, FL2 decisions2002–20030 recalls

FDA records 2 decisions for Primary Technology, LLC (Tampa, FL) from 2002 to 2003: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 5 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 Primary Technology, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Primary Technology, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Primary”

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