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Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252804

by Shenzhen Ulike Smart Electronics Co., Ltd.

Identifiers

510(k) Number
K252804 FDA 510(k)
FDA Product Code
OHT FDA 510(k)
Models / Variants
Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG FDA 510(k)
UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH FDA 510(k)
UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06RD, UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG FDA 510(k)
UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU FDA 510(k)
UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, 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)

This device is a Light-Based Over-The-Counter Hair Removal Device, designed to reduce unwanted hair through intense pulsed light (IPL) technology. It targets hair follicles with controlled light energy to inhibit regrowth, suitable for use on various skin tones and body areas as classified by its regulatory designation.

The device is supplied as a reusable, non-sterile system intended for home use. It operates with multiple interchangeable handpiece models (UI20S, UI20, UI06, UI06S, UI04) and requires no regulatory sterilisation. Compliance with FDA 510(k) clearance under Special Review (K252804) and classification as a Class II device (878.4810) confirms its authorised use for over-the-counter hair removal. Storage follows manufacturer guidelines to preserve functionality.

Frequently asked questions

What types of skin tones and body areas can this device be used on according to its regulatory classification?

This device is classified as a Light-Based Over-The-Counter Hair Removal Device under FDA product code OHT (878.4810) and is designed to target unwanted hair through intense pulsed light (IPL) technology. While the exact skin tones and body areas are not explicitly detailed in the data, the regulatory designation implies it is intended for general use on various skin tones and body areas suitable for IPL hair removal, as classified by the manufacturer and approved under FDA 510(k) clearance.

Is this device single-use or reusable, and does it require sterilization?

The device is explicitly described as a reusable, non-sterile system intended for home use. Since it is non-sterile, it does not require regulatory sterilization, and users should follow manufacturer guidelines for cleaning and maintenance to preserve functionality.

How many interchangeable handpiece models are available, and what are the key differences between them?

The device comes with multiple interchangeable handpiece models, including UI20S, UI20, UI06, UI06S, and UI04 series, each with distinct color-coded variants (e.g., BK, BS, GP, WH). While the exact functional differences between these models are not detailed, the variety suggests they may be designed for different body areas or hair densities, allowing users to select the appropriate handpiece for their needs.

What storage instructions should I follow to maintain the device’s functionality?

The device requires adherence to manufacturer-provided storage guidelines to preserve its functionality. Since it is reusable and non-sterile, proper storage likely involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures, though specific instructions are not provided in the data. Always refer to the user manual for precise guidance.

What regulatory pathway was followed for FDA clearance, and what does this mean for users?

The device received FDA 510(k) clearance under Special Review (K252804), classified as a Class II device (878.4810). This means it was determined to be substantially equivalent to a legally marketed predicate device and is authorized for over-the-counter hair removal. Users can rely on this clearance as confirmation of its safety and effectiveness for its intended use as described in the data.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Ulike Smart Electronics Co., Ltd.

Sources (1)

  • FDA 510(k) K252804 24 fields · synced Sep 19, 2026