meddevicedb.com FDA Device Reference

Kerasave

DEN200063 Class II Post-NSE
Decision Date
2022-05-02
Sponsor / Applicant
Al.Chi.Mi.A. S.R.L

Technical Specification

510(k) Submission ID DEN200063
Product Code QCW
Medical Specialty / Panel Ophthalmic
Regulation Citation 21 CFR 886.4320
Decision Date 2022-05-02
Clearance Pathway Post-NSE

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

Kerasave received FDA 510(k) clearance under submission number DEN200063, sponsored by Al.Chi.Mi.A. S.R.L. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2022-05-02.

Classification & Regulation

This clearance is catalogued under FDA product code QCW and 21 CFR 886.4320, within the Ophthalmic review panel as a Class II device.