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

Light Based Imaging

21 CFR 878.4580 / General, Plastic Surgery
FDA source (opens on fda.gov)

PSN is the FDA product code for Light Based Imaging, a class II device type, regulated under 21 CFR 878.4580. FDA's definition for this code reads: "Emission and collection of light to create an image for medical purposes". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PSN
Device name
Light Based Imaging
FDA definition
Emission and collection of light to create an image for medical purposes
Regulation
21 CFR 878.4580
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
Yes
Ingested clearances
10
Ingested recalls
0

Clearances, product code PSN

By decision year
10 clearances under product code PSN with a decision year between 2002 and 2023, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PSN by decision year
YearClearances
20021
20031
20041
20071
20081
20181
20191
20211
20221
20231

Applicants with the most clearances

Product code PSN
Applicants holding the most 510(k) clearances under product code PSN
ApplicantClearances
Astron Clinica Limited3
Barco N.V.3
Caliber Imaging & Diagnostics, Inc.1
Deepx Health, LLC1
Lucid, Inc.1
Visiomed AG1

Companies listing this code with FDA

Companies whose registered establishments list this code