SkinPen Precision Elite System— 510(k) K241400

Substantially Equivalent

Crown Aesthetics

FDA 510(k) clearance K241400 for SkinPen Precision Elite System, Substantially Equivalent on 2024-08-29. Applicant: Crown Aesthetics. Device class: 2.

Clearance details

Applicant
Crown Aesthetics
Product code
Code QAI
Device class
Class 2
Regulation
21 CFR 878.4430
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dallas, TX, US
Download summary PDFView on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.