Home / 510(k) Clearances / K243591

510(k) K243591

OPTOVISION Endoscopic Light Source Unit by Optosurgical, LLC — Product Code OWN

K243591 is an FDA 510(k) premarket notification submitted by Optosurgical, LLC for the device "OPTOVISION Endoscopic Light Source Unit". The FDA issued a decision of Substantially Equivalent on February 19, 2025. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2025
Date Received
November 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Confocal Optical Imaging
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Collection of light signals for visualization of cellular microstructures.

Other clearances for product code OWN

  • K242163 — SmartSurgN Visualization System (April 20, 2026)
  • K254242 — KARL STORZ ICG Imaging System with RUBINA® Lens (February 26, 2026)
  • K251852 — cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) (February 13, 2026)
  • K260108 — L12 LED Light Source with AIM (February 12, 2026)
  • K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040) (February 12, 2026)
  • K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE I (November 12, 2025)
  • K243711 — Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging Sys (July 24, 2025)
  • K241275 — Histolog® Scanner (Hardware 2.4, Software 3.3) (August 19, 2024)
  • K233333 — KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit (November 21, 2023)
  • K232857 — KARL STORZ ICG Imaging System (November 6, 2023)

FDA data resources