Dexter L6 System— 510(k) K260653
Substantially EquivalentDistalmotion SA
FDA 510(k) clearance K260653 for Dexter L6 System, Substantially Equivalent on 2026-06-11. Applicant: Distalmotion SA. Device class: 2.
Summary
Distalmotion's Dexter L6 System is filed under SDD, electromechanical surgical systems in which the surgeon and the user interface can be in the sterile field. The record doesn't say what "L6" refers to or list components.
Class II, 21 CFR 878.4965. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Distalmotion filed from Epalinges, Switzerland. Review took 104 calendar days (February 27 to June 11, 2026).
Clearance details
- Applicant
- Distalmotion SA
- Product code
- Product code SDD
- Device class
- Class 2
- Regulation
- 21 CFR 878.4965
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Epalinges, CH
Recent devices under product code SDD
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