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510(k) K260653

Device
Dexter L6 System
Applicant
Distalmotion SA
510(k) number
K260653
Product code
SDD
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-11
Date received
2026-02-27
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#

Contact
Caroline Bonnet
Address
Rte. De La Corniche 3b Epalinges CH 1066 1066

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SDD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251197Dexter L6 SystemDistalmotion SA2025-09-30
K250435Dexter L6 SystemDistalmotion SA2025-05-27
DEN230084Dexter L6 SystemDistalmotion SA2024-10-25