Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K242630

Aerin Console

510(k) number
K242630
Device name
Aerin Console
Applicant
Aerin Medical, Inc. CA · US
Product code
GEI — Electrosurgical, Cutting & Coagulation & Accessories
Decision date
2024-12-10
Date received
2024-09-03
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K242630.pdf

Official FDA record: K242630
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.