K241998

Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)

510(k) number: K241998
Device name: Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
Applicant: Shenzhen Ulike Smart Electronics Co., Ltd. CN
Product code: OHT — Light Based Over-The-Counter Hair Removal
Decision date: 2024-12-13
Date received: 2024-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K241998.pdf

Official FDA record: K241998

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