meddevicedb.com FDA Device Reference

SkinPen Precision System

DEN160029 Class II Direct
Decision Date
2018-03-01
Sponsor / Applicant
Bellus Medical, LLC

Technical Specification

510(k) Submission ID DEN160029
Product Code QAI
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4430
Decision Date 2018-03-01
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

SkinPen Precision System received FDA 510(k) clearance under submission number DEN160029, sponsored by Bellus Medical, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2018-03-01.

Classification & Regulation

This clearance is catalogued under FDA product code QAI and 21 CFR 878.4430, within the General, Plastic Surgery review panel as a Class II device.