Cleared Traditional

K250435 - Dexter L6 System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250435 · Distalmotion SA · General & Plastic Surgery device
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May 2025
Decision
102d
Days
Class 2
Risk

K250435 is an FDA 510(k) clearance for the Dexter L6 System. Classified as Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field (product code SDD), Class II - Special Controls.

Submitted by Distalmotion SA (Epalinges, CH). The FDA issued a Cleared decision on May 27, 2025 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4965 - 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 Distalmotion SA devices

Submission Details

510(k) Number K250435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2025
Decision Date May 27, 2025
Days to Decision 102 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
12d faster than avg
Panel avg: 114d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SDD Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4965
Definition An Electromechanical Surgical System With Transient Sterile Field Presence Of Both Surgeon And Primary Control Interface Is A Software-controlled Electromechanical System With Fully Positionable Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures. The Device Allows For Both The Surgeon And Primary Control Interface To Have Presence Inside The Sterile Field As Needed Within The Clinical Context Of Use.
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

Hogan Lovells US LLP
Lina Kontos

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.