510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OPTClass II

Infrared Hematoma Detector

21 CFR 882.1935 / Ophthalmic
FDA source (opens on fda.gov)

OPT is the FDA product code for Infrared Hematoma Detector, a class II device type, regulated under 21 CFR 882.1935. FDA's definition for this code reads: "To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OPT
Device name
Infrared Hematoma Detector
FDA definition
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
Regulation
21 CFR 882.1935
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
1

Clearances, product code OPT

By decision year
5 clearances under product code OPT with a decision year between 2011 and 2024, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OPT by decision year
YearClearances
20111
20131
20201
20221
20241

Applicants with the most clearances

Product code OPT
Applicants holding the most 510(k) clearances under product code OPT
ApplicantClearances
Infrascan, Inc.5

Companies listing this code with FDA

Companies whose registered establishments list this code