K253881

Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)

510(k) number: K253881
Device name: Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
Applicant: Shenzhen Fansizhe Science and Technology Co., Ltd. CN
Product code: OHT — Light Based Over-The-Counter Hair Removal
Decision date: 2025-12-29
Date received: 2025-12-04
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: General, Plastic Surgery

Also available from FDA: K253881.pdf

Official FDA record: K253881

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