meddevicedb.com FDA Device Reference

Ultravision Visual Clearing System

DEN150022 Class II Direct
Decision Date
2016-12-20
Sponsor / Applicant
Alesi Surgical, Ltd.

Technical Specification

510(k) Submission ID DEN150022
Product Code PQM
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.5050
Decision Date 2016-12-20
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

Ultravision Visual Clearing System received FDA 510(k) clearance under submission number DEN150022, sponsored by Alesi Surgical, Ltd.. 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 2016-12-20.

Classification & Regulation

This clearance is catalogued under FDA product code PQM and 21 CFR 878.5050, within the General, Plastic Surgery review panel as a Class II device.