510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K200542Substantially Equivalent

Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head

Olympus Medical Systems Corp., Hachioji-Shi, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200542 is the FDA 510(k) clearance record for Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head, a class II device, cleared for Olympus Medical Systems Corp. on under FDA product code OWN (Confocal Optical Imaging). FDA's definition for product code OWN reads: "Collection of light signals for visualization of cellular microstructures". FDA records list 186 510(k) clearances for Olympus Medical Systems Corp., from to . As of , FDA records show no recalls naming K200542.

Clearance record

Decision date
Received
(136 days to decision)
Product code
OWN Confocal Optical Imaging
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWN

Trailing 12 months
8 clearances under product code OWN in the twelve months to October 2026, February 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code OWN, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20264
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260