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510(k) K242924

OPXION Optical Skin Viewer (OPXSV1-01F) by Opxion Technology, Inc. — Product Code NQQ

K242924 is an FDA 510(k) premarket notification submitted by Opxion Technology, Inc. for the device "OPXION Optical Skin Viewer (OPXSV1-01F)". The FDA issued a decision of Substantially Equivalent on June 23, 2025. The device falls under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)), a Class II device regulated under 21 CFR 892.1560.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2025
Date Received
September 24, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Optical Coherence Tomography (Oct)
Device Class
Class II
Regulation Number
892.1560
Review Panel
SU
Submission Type

This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.

Other clearances for product code NQQ

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  • K251730 — LIA Console (542-7) (December 19, 2025)
  • K253101 — HyperVue™ Imaging System - Integrated (December 15, 2025)
  • K252851 — deepLive (OSP12 + DMS) (October 7, 2025)
  • K251198 — HyperVue™ Software (July 16, 2025)
  • K250684 — OPUSWAVE Dual Sensor Imaging System (July 2, 2025)
  • K242098 — Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging Sy (April 11, 2025)
  • K243016 — Starlight Imaging Catheter (March 20, 2025)
  • K242239 — HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), (August 16, 2024)
  • K240610 — deepLive (July 9, 2024)

FDA data resources