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FDA 510(k)

IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439

K-Number: K222432 · 2022-10-11

ApplicantHunan Guangye Biotechnology Co., Ltd.
Decision Date2022-10-11
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 is a medical device manufactured by Hunan Guangye Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-11 under approval number K222432. 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): KCA423, KCA437, KCA439?

IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 is a medical device that received FDA 510(k) clearance on 2022-10-11. It is manufactured by Hunan Guangye Biotechnology Co., Ltd.. The 510(k) number is K222432.

When was IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 approved by the FDA?

IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 received FDA 510(k) clearance on 2022-10-11, under approval number K222432.

What company makes IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439?

IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 is manufactured by Hunan Guangye Biotechnology Co., Ltd..

What is the FDA product code for IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439?

The FDA product code for IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 is OHT.

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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)

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Official Source

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

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