OPXION Optical Skin Viewer (OPXSV1-01F)— 510(k) K242924

Substantially Equivalent

Opxion Technology, Inc.

FDA 510(k) clearance K242924 for OPXION Optical Skin Viewer (OPXSV1-01F), Substantially Equivalent on 2025-06-23. Applicant: Opxion Technology, Inc.. Device class: 2.

Clearance details

Applicant
Opxion Technology, Inc.
Product code
Code NQQ
Device class
Class 2
Regulation
21 CFR 892.1560
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New Taipei City, TW
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