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Ice Cooling IPL Hair Removal Device - UI20S BS

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241998

by Shenzhen Ulike Smart Electronics Co., Ltd.

Identifiers

510(k) Number
K241998 FDA 510(k)
FDA Product Code
OHT FDA 510(k)
Models / Variants
UI20 DB FDA 510(k)EUDAMED
UI20 RE FDA 510(k)EUDAMED
UI20 GP FDA 510(k)EUDAMED
UI20 PW FDA 510(k)EUDAMED
UI20S DB FDA 510(k)EUDAMED
UI20S RE FDA 510(k)EUDAMED
UI20S PW FDA 510(k)EUDAMED
UI20S GP FDA 510(k)EUDAMED
UI20 WH FDA 510(k)EUDAMED
UI20 GR FDA 510(k)EUDAMED
UI20 BS FDA 510(k)EUDAMED
UI20 MP FDA 510(k)EUDAMED
UI20 BL FDA 510(k)EUDAMED
UI20 PN FDA 510(k)EUDAMED
UI20 BR FDA 510(k)EUDAMED
UI20WG FDA 510(k)EUDAMED
UI20S WH FDA 510(k)EUDAMED
UI20S GR FDA 510(k)EUDAMED
UI20S BS FDA 510(k)EUDAMED
UI20S MP FDA 510(k)EUDAMED

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, classified under FDA category 878.4810. It employs intense pulsed light (IPL) technology to target and reduce unwanted hair through controlled energy delivery to the hair follicles. The device is designed for non-invasive hair removal and long-term hair regrowth reduction, targeting melanin in hair shafts to inhibit growth cycles.

The device is supplied as a reusable, non-sterile system intended for home or professional use. It includes multiple handpiece variants (e.g., UI20 DB, UI20S RE) with varying treatment windows for different skin tones and hair types. Authorized under FDA 510K and MDR, it requires no sterilization but must be cleaned and stored per manufacturer instructions to prevent contamination. Compliance with OpenFDA registration numbers (e.g., 3019015047) confirms regulatory filing for over-the-counter use in hair removal.

Frequently asked questions

What types of skin tones and hair types is this IPL hair removal device designed to treat?

The Ice Cooling IPL Hair Removal Device includes multiple handpiece variants (e.g., UI20 DB, UI20S RE) specifically engineered to accommodate different skin tones and hair types. The device targets melanin in hair follicles, so it is optimized for use on various skin tones and hair colors, though effectiveness may vary based on individual pigmentation and hair characteristics. Always follow manufacturer guidelines to select the appropriate handpiece for your patient’s skin tone.

Is this device reusable, and if so, how should it be maintained to ensure safety and performance?

Yes, the Ice Cooling IPL Hair Removal Device is designed as a reusable system, meaning it is not single-use. To maintain safety and performance, it must be cleaned thoroughly after each use according to the manufacturer’s instructions. Since it is non-sterile, sterilization is not required, but proper cleaning and storage are essential to prevent contamination and ensure longevity. Always store it in a clean, dry environment when not in use.

What regulatory pathways has this device undergone, and how does that affect its use?

The Ice Cooling IPL Hair Removal Device has been authorized through both the FDA’s 510(k) pathway and the EU’s Medical Device Regulation (MDR). The FDA clearance under category 878.4810 confirms it is classified as a Light-Based Over-The-Counter Hair Removal Device, intended for non-invasive hair reduction at home or in professional settings. The MDR authorization further supports its compliance for use in the EU market. These pathways ensure the device meets safety and performance standards for its intended use.

Are there different models or handpieces available, and how do they differ?

Yes, the device comes in multiple models and handpiece variants, such as UI20 DB, UI20S RE, UI20 GP, and others, each designed with varying treatment windows. These differences allow for customization based on skin tone, hair type, and treatment area. For example, some handpieces may have larger or smaller treatment areas to accommodate different body parts or skin sensitivities. Always refer to the manufacturer’s specifications to select the appropriate handpiece for your needs.

How should this device be stored to maintain its effectiveness and safety?

The Ice Cooling IPL Hair Removal Device should be stored in a clean, dry environment when not in use. Since it is reusable and non-sterile, it must be kept away from moisture, dust, and direct sunlight to prevent damage or contamination. Follow the manufacturer’s storage instructions carefully to ensure the device remains safe and effective for long-term use.

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 (UI20 DB, UI20 RE, UI20 GP, UI20 PW ..., Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW ..., Ice Cooling IPL Hair Removal Device (UI20 DB, UI20… - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Ulike Smart Electronics Co., Ltd.

Sources (2)

  • FDA 510(k) K241998 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced Jun 11, 2026