INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30— 510(k) K032704

Name: FDA 510(k) clearance K032704
Creator: U.S. Food and Drug Administration
Published: 2003-10-24

Substantially Equivalent

Innovatech Surgical, Inc.

FDA 510(k) clearance K032704 for INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30, Substantially Equivalent on 2003-10-24. Applicant: Innovatech Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Innovatech Surgical, Inc.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2003-09-02
Decision date: 2003-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camden, NJ, US

Download summary PDF View on FDA.gov ↗

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K032703 — INNOVATECH STRAIGHT LASER PROBE, MODEL 420-102003-10-24

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.