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510(k) K243016

Starlight Imaging Catheter by Spectrawave, Inc. — Product Code NQQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2025
Date Received
September 27, 2024
Clearance Type
Special
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 by Spectrawave, Inc.

  • K253101 — HyperVue™ Imaging System - Integrated (December 15, 2025)
  • K251355 — X1-FFR (October 17, 2025)
  • K251198 — HyperVue™ Software (July 16, 2025)
  • K230691 — HyperVue™ Imaging System (June 7, 2023)
  • K221257 — SpectraWAVE Imaging System (February 28, 2023)

Other clearances for product code NQQ

  • 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)
  • K242924 — OPXION Optical Skin Viewer (OPXSV1-01F) (June 23, 2025)
  • K242098 — Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging Sy (April 11, 2025)
  • K242239 — HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), (August 16, 2024)
  • K240610 — deepLive (July 9, 2024)
  • K232386 — ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with Apt (September 8, 2023)