X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)— 510(k) K230611

Name: FDA 510(k) clearance K230611
Creator: U.S. Food and Drug Administration
Published: 2023-07-13

Substantially Equivalent

Xstrahl, Ltd.

FDA 510(k) clearance K230611 for X80 / RADiant / PhotoElectric Therapy System (RADiant Aura), Substantially Equivalent on 2023-07-13. Applicant: Xstrahl, Ltd.. Device class: 2.

Clearance details

Applicant: Xstrahl, Ltd.
Product code: Code JAD
Device class: Class 2
Regulation: 21 CFR 892.5900
Advisory panel: Radiology
Date received: 2023-03-06
Decision date: 2023-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brownhills, GB

Download summary PDF View on FDA.gov ↗

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