K243085

IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)

510(k) number
K243085
Device name
IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)
Applicant
Zhuzhou Goldenhot Medical Technology Co., Ltd. CN
Product code
OHT — Light Based Over-The-Counter Hair Removal
Decision date
2024-12-21
Date received
2024-09-30
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain

Also available from FDA: K243085.pdf

Official FDA record: K243085
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.