510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213840Substantially Equivalent

MolecuLight I:X

Moleculight Corp, Toronto, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213840 is the FDA 510(k) clearance record for MolecuLight I:X, a class II device, cleared for MolecuLight, Inc. on under FDA product code QJF (Autofluorescence Imaging Adjunct Tool For Wounds). FDA's definition for product code QJF reads: "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". FDA records list 5 510(k) clearances for MolecuLight, Inc., from to . As of , FDA records show no recalls naming K213840.

Clearance record

Decision date
Received
(160 days to decision)
Product code
QJF Autofluorescence Imaging Adjunct Tool For Wounds
Regulation
21 CFR 878.4550
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
MolecuLight, Inc. Suite 700, 425 University Ave., Toronto, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJF

Trailing 12 months
1 clearance under product code QJF in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QJF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260