510(k) K250224— handLITE (TN19S)

Substantially Equivalent

iSMART Developments, Ltd.

Clearance details

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

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