Cleared Traditional

K242067 - VISERA ELITE III VIDEO SYSTEM CENTER OL...

Also marketed or referenced as:
VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA

K242067 is an FDA 510(k) clearance for VISERA ELITE III VIDEO SYSTEM CENTER OL..., manufactured by Olympus Corporations of the Americas. The device is a Class 2 General & Plastic Surgery device with product code FET cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K242067 · Olympus Corporations of the Americas · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
261d
Days
Class 2
Risk

K242067 is an FDA 510(k) clearance for the VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Olympus Corporations of the Americas (Westborough, US). The FDA issued a Cleared decision on April 2, 2025 after a review of 261 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Corporations of the Americas devices

FDA 510(k) Submission Details - K242067

510(k) Number K242067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2024
Decision Date April 02, 2025
Days to Decision 261 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 115d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FET Device Classification - Class 2, Special Controls

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 61
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K242067.
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Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
K241532 · Shanghai SeeGen Photoelectric Technology Co., Ltd. · Oct 2024
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
K241371 · Olympus Medical Systems Corporation · Jul 2024