K233024

Alma Harmony

510(k) number
K233024
Device name
Alma Harmony
Applicant
Alma Lasers, Inc. IL · US
Product code
GEX — Powered Laser Surgical Instrument
Decision date
2024-02-08
Date received
2023-09-22
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain

Also available from FDA: K233024.pdf

Official FDA record: K233024
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.