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

Autofluorescence Imaging Adjunct Tool For Wounds

21 CFR 878.4550 / General, Plastic Surgery
FDA source (opens on fda.gov)

QJF is the FDA product code for Autofluorescence Imaging Adjunct Tool For Wounds, a class II device type, regulated under 21 CFR 878.4550. FDA's definition for this code 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". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QJF
Device name
Autofluorescence Imaging Adjunct Tool For Wounds
FDA 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.
Regulation
21 CFR 878.4550
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
1

Clearances, product code QJF

By decision year
7 clearances under product code QJF with a decision year between 2019 and 2026, 2021 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QJF by decision year
YearClearances
20191
20212
20221
20231
20251
20261

Applicants with the most clearances

Product code QJF
Applicants holding the most 510(k) clearances under product code QJF
ApplicantClearances
Moleculight Corp4
Kent Imaging Inc1
Precision Healing, LLC1
Swift Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code