SculpSure— 510(k) K182741

Substantially Equivalent

Cynosure

FDA 510(k) clearance K182741 for SculpSure, Substantially Equivalent on 2019-01-03. Applicant: Cynosure. Device class: 2.

Clearance details

Applicant: Cynosure
Product code: Code PKT
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2018-09-28
Decision date: 2019-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wesford, MA, US

Download summary PDF View on FDA.gov ↗

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