OPT80 THE TRANSPORTABLE (OPT80)— 510(k) K972810

Name: FDA 510(k) clearance K972810
Creator: U.S. Food and Drug Administration
Published: 1997-08-26

Substantially Equivalent

O.P.T. USA, Inc.

FDA 510(k) clearance K972810 for OPT80 THE TRANSPORTABLE (OPT80), Substantially Equivalent on 1997-08-26. Applicant: O.P.T. USA, Inc.. Device class: 1.

Clearance details

Applicant: O.P.T. USA, Inc.
Product code: Code FQO
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1997-07-28
Decision date: 1997-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FQO

product code FQO

Death: 6
Injury: 145
Malfunction: 685
Total: 836

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.