510(k) K250435

Device: Dexter L6 System
Applicant: Distalmotion SA
510(k) number: K250435
Product code: SDD
Decision: Substantially Equivalent (SESE)
Decision date: 2025-05-27
Date received: 2025-02-14
Regulation: 878.4965
Classification name: Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
Medical specialty: General, Plastic Surgery
Review panel: General, Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K251197	Dexter L6 System	Distalmotion SA	2025-09-30
DEN230084	Dexter L6 System	Distalmotion SA	2024-10-25