Accent XL— 510(k) K160075

Substantially Equivalent

Alma Lasers, Inc.

FDA 510(k) clearance K160075 for Accent XL, Substantially Equivalent on 2016-08-17. Applicant: Alma Lasers, Inc.. Device class: 2.

Clearance details

Applicant: Alma Lasers, Inc.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2016-01-14
Decision date: 2016-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo Grove, IL, 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.