PLS PORTABLE LIGHT SOURCE— 510(k) K091829

Name: FDA 510(k) clearance K091829
Creator: U.S. Food and Drug Administration
Published: 2009-07-28

Substantially Equivalent

Optim, Inc.

FDA 510(k) clearance K091829 for PLS PORTABLE LIGHT SOURCE, Substantially Equivalent on 2009-07-28. Applicant: Optim, Inc.. Device class: 2.

Clearance details

Applicant: Optim, Inc.
Product code: Code NTN
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-06-19
Decision date: 2009-07-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sturbridge, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NTN

product code NTN

Other: 1
Total: 1

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.