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

QPE · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4880

Classification

FDA Product Code: QPE
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4880
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown