Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IPL Hair Removal Device (KCA511/KCA516/KCA522)

K-Number: K250253 · 2025-05-06

ApplicantDongguan Boyuan Intelligent Technology Co.,Ltd
Decision Date2025-05-06
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device (KCA511/KCA516/KCA522) is a medical device manufactured by Dongguan Boyuan Intelligent Technology Co.,Ltd. It received FDA 510(k) clearance on 2025-05-06 under approval number K250253. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPL Hair Removal Device (KCA511/KCA516/KCA522)?

IPL Hair Removal Device (KCA511/KCA516/KCA522) is a medical device that received FDA 510(k) clearance on 2025-05-06. It is manufactured by Dongguan Boyuan Intelligent Technology Co.,Ltd. The 510(k) number is K250253.

When was IPL Hair Removal Device (KCA511/KCA516/KCA522) approved by the FDA?

IPL Hair Removal Device (KCA511/KCA516/KCA522) received FDA 510(k) clearance on 2025-05-06, under approval number K250253.

What company makes IPL Hair Removal Device (KCA511/KCA516/KCA522)?

IPL Hair Removal Device (KCA511/KCA516/KCA522) is manufactured by Dongguan Boyuan Intelligent Technology Co.,Ltd.

What is the FDA product code for IPL Hair Removal Device (KCA511/KCA516/KCA522)?

The FDA product code for IPL Hair Removal Device (KCA511/KCA516/KCA522) is OHT.

Related Clinical Trials

NCT07062094 Safety and Effectiveness of Orbera365™ Intragastric Balloon System RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT06430268 Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants ENROLLING_BY_INVITATION NCT05729477 A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device TERMINATED NCT03795675 CI Following VS Removal or Labyrinthectomy ACTIVE_NOT_RECRUITING NCT05901038 Development of Artefact Removal and Physical Activity Algorithm COMPLETED

Other Devices by Dongguan Boyuan Intelligent Technology Co.,Ltd

K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) K240282IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521) K250308Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)

Related Devices (Code: OHT)

K162231iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expertCyden Limited K161089sensiLight MiniEl Global Trade, Ltd. K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited K172181micro IPLEl Global Trade, Ltd. K171433Silk'n InfinityHome Skinovations , Ltd. K170269Hee HR MiniOriental Inspiration Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑