K251173

Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)

510(k) number: K251173
Device name: Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
Applicant: Shenzhen Fansizhe Science and Technology Co., Ltd. CN
Product code: OHT — Light Based Over-The-Counter Hair Removal
Decision date: 2025-07-14
Date received: 2025-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain

Also available from FDA: K251173.pdf

Official FDA record: K251173

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