510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN180008Unknown

MolecuLight i:X

Moleculight Corp, Toronto, CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN180008 is the FDA 510(k) clearance record for MolecuLight i:X, a class I device, cleared for MolecuLight, Inc. on under FDA product code QCR (Wound Autofluorescence Imaging Device). FDA's definition for product code QCR reads: "A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information". FDA records list 5 510(k) clearances for MolecuLight, Inc., from to . As of , FDA records show no recalls naming DEN180008.

Clearance record

Decision date
Received
(165 days to decision)
Product code
QCR Wound Autofluorescence Imaging Device
Regulation
21 CFR 878.4165
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
MolecuLight, Inc. 101 College St., Suite 200, Toronto, CA
Third party review
No

Clearances, product code QCR

Trailing 12 months

FDA records hold no clearances under product code QCR in the trailing twelve months.

FDA records show no clearances under product code QCR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QCR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260