FDA product code QPE

Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions

General, Plastic Surgery·Class 2·21 CFR 878.4880
US regulatory classifications
US Product Code (FDA)
QPE
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4880
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

This device consists of a light emitting device and a photoconverter gel and is intended to employ light energy for reducing the appearance of acute post-surgical incisions. This classification does not include products which contain drugs or biologics.

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About this record

Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.