510(k) K081307— OMNILUX CLEAR-U

Substantially Equivalent

Photo Therapeutics, Inc.

Clearance details

Applicant
Photo Therapeutics, Inc.
Product code
Code OLP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code OLP

product code OLP
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.