Infrascanner Model 2500 (Model 2500)— 510(k) K241389

Name: FDA 510(k) clearance K241389
Creator: U.S. Food and Drug Administration
Published: 2024-12-12

Substantially Equivalent

Infrascan, Inc.

FDA 510(k) clearance K241389 for Infrascanner Model 2500 (Model 2500), Substantially Equivalent on 2024-12-12. Applicant: Infrascan, Inc.. Device class: 2.

Clearance details

Applicant: Infrascan, Inc.
Product code: Code OPT
Device class: Class 2
Regulation: 21 CFR 882.1935
Advisory panel: Ophthalmic
Date received: 2024-05-15
Decision date: 2024-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

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