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Sign in to claim this brandShenzhen Ionka Medical Technology Co., Ltd.
US
Last updated May 25, 2026
What Shenzhen Ionka Medical Technology Co., Ltd. makes
The company manufactures home-use intense pulsed light (IPL) devices designed for hair removal. These are handheld units intended for consumer use, including models such as the FZ-608, FZ-608G, FZ-100, and FZ-200.
The portfolio consists of Class II medical devices, authorised via FDA 510(k) clearance and listed under the FDA’s Unique Device Identifier (UDI) system. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Shenzhen Ionka Medical Technology Co., Ltd. manufacture?
Shenzhen Ionka Medical Technology Co., Ltd. specialises in home-use intense pulsed light (IPL) devices. These are handheld units designed specifically for consumer hair removal, such as models like the FZ-608, FZ-608G, FZ-100, and FZ-200. The devices fall under the category of IPL hair removal technology, which uses controlled light pulses to target and reduce hair growth.
Where is Shenzhen Ionka Medical Technology Co., Ltd. based?
The company is based in the United States. While its name suggests a Shenzhen origin, its operational headquarters and regulatory filings are associated with the US market, where its devices are authorised.
Which regulatory registries or databases list Shenzhen Ionka Medical Technology Co., Ltd.’s devices?
The company’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries confirm the devices’ classification and compliance pathways, ensuring transparency for users and regulators.
How are Shenzhen Ionka Medical Technology Co., Ltd.’s devices classified under medical device regulations?
The company’s devices are classified as Class II medical devices. This classification is determined by the FDA based on the risk associated with the device’s intended use—here, home-use IPL hair removal—which requires special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 707411576
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hand-held IPL device (IPL Home Use Hair Removal Device) | FZ-200 | FDA UDI | Class II | Active |
| Hand-held IPL device (IPL Home Use Hair Removal Device) | FZ-608G | FDA UDI | Class II | Active |
| Hand-held IPL device (IPL Home Use Hair Removal Device) | FZ-608 | FDA UDI | Class II | Active |
| Hand-held IPL device (IPL Home Use Hair Removal Device) | FZ-100 | FDA UDI | Class II | Active |
| Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 | K221214 | FDA 510(k) | Class II | Active |
| Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 | K230739 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Shenzhen IONKA Medical Technology Co., Ltd. Shenzhen Guangdong · CN FEI 3026132991