Cleared Traditional

K251336 - VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700)

Also marketed or referenced as:
VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700) 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)

K251336 is an FDA 510(k) clearance for VISERA ELITE III Video System Center Ol..., manufactured by Olympus Medical Systems Corp.. The device is a Class 2 General & Plastic Surgery device with product code OWN cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K251336 · Olympus Medical Systems Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
196d
Days
Class 2
Risk

K251336 is an FDA 510(k) clearance for the VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700). Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on November 12, 2025 after a review of 196 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 Medical Systems Corp. devices

FDA 510(k) Submission Details - K251336

510(k) Number K251336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2025
Decision Date November 12, 2025
Days to Decision 196 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
81d slower than avg
Panel avg: 115d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWN Device Classification - Class 2, Special Controls

Product Code OWN Confocal Optical Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.
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 Consultant

Olympus Surgical Technologies of the Americas
Darlene Hull

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OWN Confocal Optical Imaging

All 61
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