Product code OPT— Ophthalmic

Infrascanner

Classification name: Infrared Hematoma Detector
Device class: Class 2
Regulation: 21 CFR 882.1935
Advisory panel: Ophthalmic
Total cleared: 5
First cleared: 2011-12-13
Most recent: 2024-12-12

FDA classification definition

“To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.”
— U.S. Food and Drug Administration, device classification record for product code OPT under 21 CFR 882.1935, via openFDA

Market context for product code OPT

FDA has cleared 5 devices under product code OPT between 2011 and 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20241 clearance
20221 clearance
20201 clearance
20131 clearance
20111 clearance

Top applicants under product code OPT

Infrascan, Inc.5 clearances

Recent clearances under product code OPT

K241389 — Infrascanner Model 2500 (Model 2500)Infrascan, Inc.·2024-12-12
K211617 — InfrascannerInfrascan, Inc.·2022-02-09
K200203 — InfrascannerInfrascan, Inc.·2020-07-10
K120949 — INFRASCANNERInfrascan, Inc.·2013-01-11
DEN100002 — INFRASCANNER, MODEL 1000Infrascan, Inc.·2011-12-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.