handLITE (TN19S)— 510(k) K250224

Substantially Equivalent

iSMART Developments, Ltd.

FDA 510(k) clearance K250224 for handLITE (TN19S), Substantially Equivalent on 2025-04-18. Applicant: iSMART Developments, Ltd.. Device class: 2.

Clearance details

Applicant: iSMART Developments, Ltd.
Product code: Code ONE
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-01-27
Decision date: 2025-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

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More clearances from iSMART Developments, Ltd.

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Data sourced from openFDA. This site is unofficial and independent of the FDA.