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FDA 510(k)

Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200

K-Number: K221214 · 2022-09-21

ApplicantShenzhen Ionka Medical Technology Co., Ltd.
Decision Date2022-09-21
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 is a medical device manufactured by Shenzhen Ionka Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-09-21 under approval number K221214. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200?

Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 is a medical device that received FDA 510(k) clearance on 2022-09-21. It is manufactured by Shenzhen Ionka Medical Technology Co., Ltd.. The 510(k) number is K221214.

When was Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 approved by the FDA?

Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 received FDA 510(k) clearance on 2022-09-21, under approval number K221214.

What company makes Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200?

Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 is manufactured by Shenzhen Ionka Medical Technology Co., Ltd..

What is the FDA product code for Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200?

The FDA product code for Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 is ONF.

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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)

Other Devices by Shenzhen Ionka Medical Technology Co., Ltd.

K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200

Related Devices (Code: ONF)

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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.

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