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Ice Cooling IPL Hair Removal Device - Y6S JM

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241205

by Shenzhen Ulike Smart Electronics Co., Ltd.

Identifiers

510(k) Number
K241205 FDA 510(k)
FDA Product Code
OHT FDA 510(k)
Models / Variants
Y6S GR FDA 510(k)
Y6S GA FDA 510(k)
Y6S GT FDA 510(k)
Y6S JU FDA 510(k)
Y6S JM FDA 510(k)
Y6S MU FDA 510(k)
Y6S OG FDA 510(k)
Y6S CH FDA 510(k)
Y6S PN FDA 510(k)
Y6S NK FDA 510(k)
Y6S PG FDA 510(k)
Y6S TG FDA 510(k)
Y6S OE 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 device is a light-based over-the-counter hair removal system that uses intense pulsed light (IPL) technology to target hair follicles and reduce hair growth. It incorporates an ice cooling feature to help protect the skin surface during treatment. The device is classified as a class II medical device under product code OHT and is cleared for over-the-counter use.

The device is intended for single-user home application and is supplied with multiple model variants indicated by the Y6S codes. It is manufactured by Shenzhen Ulike Smart Electronics Co., Ltd. and received FDA 510(k) clearance under number K241205. The device is regulated under 21 CFR 878.4810 and is subject to UDI labeling requirements. Storage and handling instructions are not specified in the available data.

Frequently asked questions

What is the device intended to do?

The device is an over-the-counter hair removal system that uses intense pulsed light (IPL) to target hair follicles and reduce hair growth. It includes an ice cooling feature to protect the skin surface during treatment and is intended for single-user home application.

How is the device supplied?

The device is supplied as a complete system with multiple model variants identified by Y6S codes, including Y6S GR, Y6S GA, Y6S GT, and others. Each variant is a distinct SKU intended for single-user home use.

Is the device sterile?

The device data does not specify whether the device is supplied sterile or requires sterilization prior to use. No sterilization method or claim is mentioned in the available regulatory or product information.

Is the device for single use or can it be reused?

The device is designed for single-user home application. It is not described as a disposable or single-use item, but its intended use is limited to one individual for repeated home treatments.

What regulatory clearance does this device have?

The device received FDA 510(k) clearance under number K241205. It is classified as a class II medical device under product code OHT and is regulated under 21 CFR 878.4810. The clearance was granted on September 9, 2024, based on a determination of substantial equivalence.

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: Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S ..., Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S ..., PDF K241205 - Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT ...

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) K241205 24 fields · synced Oct 6, 2026