DeviceClearance

STARLITE-OM, LIGHT EFFECTS, THIBIANT— 510(k) K133546

Substantially Equivalent

Ps Advanced Engineering

FDA 510(k) clearance K133546 for STARLITE-OM, LIGHT EFFECTS, THIBIANT, Substantially Equivalent on 2014-08-06. Applicant: Ps Advanced Engineering. Device class: 2.

Clearance details

Applicant
Ps Advanced Engineering
Product code
Code OHS
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alhambra, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OHS

product code OHS
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.