meddevicedb.com FDA Device Reference

MolecuLight i:X

DEN180008 Class I Direct
Decision Date
2018-07-31
Sponsor / Applicant
MolecuLight, Inc.

Technical Specification

510(k) Submission ID DEN180008
Product Code QCR
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4165
Decision Date 2018-07-31
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

MolecuLight i:X received FDA 510(k) clearance under submission number DEN180008, sponsored by MolecuLight, Inc.. 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 2018-07-31.

Classification & Regulation

This clearance is catalogued under FDA product code QCR and 21 CFR 878.4165, within the General, Plastic Surgery review panel as a Class I device.