IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230122 FDA 510(k)
- FDA Product Code
- OHT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The IPL Hair Removal Device is an over-the-counter, home-use device for hair reduction. It uses Intense Pulsed Light (IPL) generated by a Xenon arc flashlamp to target hair follicles below the skin surface.
The device is supplied as a Class 2 medical device with product code OHT, cleared through the Traditional 510(k) pathway. It is intended for use in general and plastic surgery settings, with FDA clearance number K230122 received on January 17, 2023, and decision date of April 10, 2023.
Frequently asked questions
What is the IPL Hair Removal Device used for?
The IPL Hair Removal Device is an over-the-counter, home-use device designed for hair reduction. It uses Intense Pulsed Light (IPL) generated by a Xenon arc flashlamp to target hair follicles below the skin surface.
How is the IPL Hair Removal Device supplied?
The device is supplied as a Class 2 medical device with product code OHT. It is intended for use in general and plastic surgery settings and is available in models UI04 SD and UI04 DG.
What is the regulatory status of this device?
The IPL Hair Removal Device has FDA clearance through the Traditional 510(k) pathway with clearance number K230122 received on January 17, 2023, and decision date of April 10, 2023. It is classified as substantially equivalent.
Is the IPL Hair Removal Device reusable or single-use?
The device information does not specify whether it is reusable or single-use. This detail would be found in the product's user manual or packaging materials provided by the manufacturer.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: IPL Hair Removal Device, Model (s): UI04 SD, UI04 DG, IPL Hair Removal Device, Model (s): UI04 SD, UI04 DG, K230122 FDA 510 (k) - IPL Hair Removal Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230122 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Ulike Smart Electronics Co., Ltd.
Sources (1)
- FDA 510(k) K230122 24 fields · synced Sep 26, 2026