Cleared Special

MolecuLightDX

K211901 · Moleculight, Inc. · General & Plastic Surgery
Jul 2021
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K211901 is an FDA 510(k) clearance for the MolecuLightDX, a Autofluorescence Imaging Adjunct Tool For Wounds (Class II — Special Controls, product code QJF), submitted by Moleculight, Inc. (Toronto, CA). The FDA issued a Cleared decision on July 21, 2021, 30 days after receiving the submission on June 21, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4550.

Submission Details

510(k) Number K211901 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2021
Decision Date July 21, 2021
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code QJF — Autofluorescence Imaging Adjunct Tool For Wounds
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4550
Definition An Autofluorescence Detection Device For General Surgery And Dermatological Use Is An Adjunct Tool That Uses Autofluorescence To Detect Tissues Or Structures. This Device Is Not Intended To Provide A Diagnosis.