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, Model(s): T1, T2, T3, T7, T10

K-Number: K232183 · 2023-09-22

ApplicantShenzhen Koli Technology Co.,Ltd
Decision Date2023-09-22
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 is a medical device manufactured by Shenzhen Koli Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-09-22 under approval number K232183. 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, Model(s): T1, T2, T3, T7, T10?

IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 is a medical device that received FDA 510(k) clearance on 2023-09-22. It is manufactured by Shenzhen Koli Technology Co.,Ltd. The 510(k) number is K232183.

When was IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 approved by the FDA?

IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 received FDA 510(k) clearance on 2023-09-22, under approval number K232183.

What company makes IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10?

IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 is manufactured by Shenzhen Koli Technology Co.,Ltd.

What is the FDA product code for IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10?

The FDA product code for IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 is OHT.

Related Clinical Trials

NCT06291818 Self-Adhering Magnetic Device to Treat Corneal Exposure RECRUITING NCT07062094 Safety and Effectiveness of Orbera365™ Intragastric Balloon System RECRUITING NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_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

Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 40408133 A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study. Journal of medical Internet research (2025)

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.

↑