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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Ionka Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-09-21 under 510(k) 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. The listed applicant is Shenzhen Ionka Medical Technology Co., Ltd.. The 510(k) number is K221214.

When did Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 receive FDA 510(k) clearance?

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 510(k) number K221214.

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

The FDA 510(k) record lists Shenzhen Ionka Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07288593INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity InterventionNOT_YET_RECRUITINGNCT07639658Temple Massager System Study in Women Ages 35-65NOT_YET_RECRUITING

Other records listing Shenzhen Ionka Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: ONF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.

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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