MolecuLight I:X

Wound Autofluorescence Imaging Device

MolecuLight Inc.

The following data is part of a De Novo classification by Moleculight Inc. with the FDA for Moleculight I:x.

Pre-market Notification Details

DeNovo IDDEN180008
Device Name:MolecuLight I:X
ClassificationWound Autofluorescence Imaging Device
Applicant MolecuLight Inc. 101 College St. Suite 200 Toronto,  CA M5g 1l7
ContactJeffrey K. Shapiro
Product CodeQCR  
CFR Regulation Number878.4165 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGeneral & Plastic Surgery
Classification AdvisoryGeneral & Plastic Surgery
TypeDirect
Date Received2018-02-16
Decision Date2018-07-31
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.