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Ice Cooling IPL Hair Removal Device (UI20 DB +19 more)

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K241998Ref UI06S PNModel UI04B, UI20 Series, UI20S Series, UI04S Series, UI06S Series, MI01 SeriesRef UI20 WHRef MI01 LPRef UI20S WHRef UI06S PRRef UI20S PWRef UI20S BKRef MI01 PPRef UI20S MPRef MI01 RMRef UI20S GPRef UI04S PPRef UI04S WHRef UI04S BURef UI20S DBRef UI20S RERef MI01 GR

by Shenzhen Ulike Smart Electronics Co., Ltd.

Identity

Trade Name
Ulike FDA UDI
Generic Name
Home-use intense pulsed light hair removal unit FDA UDI
Device Name
Ice Cooling IPL Hair Removal Device EUDAMED
Model / Reference
MI01 PP EUDAMEDFDA UDI
UI04S WH EUDAMEDFDA UDI
UI20S MP EUDAMEDFDA UDI
MI01 LP EUDAMEDFDA UDI
UI20S WH EUDAMEDFDA UDI
UI20S BK EUDAMEDFDA UDI
MI01 RM EUDAMEDFDA UDI
UI04S PP EUDAMEDFDA UDI
MI01 GR EUDAMEDFDA UDI
UI06S PN EUDAMEDFDA UDI
UI06S PR EUDAMEDFDA UDI
UI04S BU EUDAMEDFDA UDI
UI04B, UI20 Series, UI20S Series, UI04S Series, UI06S Series, MI01 Series EUDAMED
UI20 WH EUDAMED
UI20S PW EUDAMED
UI20S GP EUDAMED
UI20S DB EUDAMED
UI20S RE EUDAMED

Identifiers

Primary DI / UDI-DI
06974667824887 EUDAMED
06974667824665 EUDAMED
06974667824559 EUDAMED
06974667824771 EUDAMED
06974667824856 EUDAMED
06974667824832 EUDAMED
06974667824849 EUDAMED
06974667824627 EUDAMED
06974667824788 EUDAMED
06974667824634 EUDAMED
06974667824825 EUDAMED
06974667824573 EUDAMED
06974667824597 EUDAMED
06974667824580 EUDAMED
06974667824801 EUDAMED
06974667824818 EUDAMED
06974667824603 EUDAMED
06974667825976 FDA UDI
06974667826133 FDA UDI
06974667825907 FDA UDI
06974667825945 FDA UDI
06974667825877 FDA UDI
06974667826966 FDA UDI
06974667825983 FDA UDI
06974667826119 FDA UDI
06974667825969 FDA UDI
06974667825921 FDA UDI
06974667825914 FDA UDI
06974667826126 FDA UDI
Basic UDI-DI
697466782IPLYC EUDAMED
Direct Marketing DI
06974667824887 EUDAMED
06974667824665 EUDAMED
06974667824559 EUDAMED
06974667824771 EUDAMED
06974667824856 EUDAMED
06974667824832 EUDAMED
06974667824849 EUDAMED
06974667824627 EUDAMED
06974667824788 EUDAMED
06974667824634 EUDAMED
06974667824825 EUDAMED
06974667824573 EUDAMED
06974667824597 EUDAMED
06974667824580 EUDAMED
06974667824801 EUDAMED
06974667824818 EUDAMED
06974667824603 EUDAMED
510(k) Number
K241998 FDA 510(k)
FDA Product Code
OHT FDA 510(k)FDA UDI
EMDN Code
X0502 HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – INTENSE PULSED LIGHT EUDAMED
GMDN Term
Home-use intense pulsed light hair removal unit FDA UDI
Models / Variants
UI20 DB FDA 510(k)FDA UDIEUDAMED
UI20 RE FDA 510(k)FDA UDIEUDAMED
UI20 GP FDA 510(k)FDA UDIEUDAMED
UI20 PW FDA 510(k)FDA UDIEUDAMED
UI20S DB FDA 510(k)FDA UDIEUDAMED
UI20S RE FDA 510(k)FDA UDIEUDAMED
UI20S PW FDA 510(k)FDA UDIEUDAMED
UI20S GP FDA 510(k)FDA UDIEUDAMED
UI20 WH FDA 510(k)FDA UDIEUDAMED
UI20 GR FDA 510(k)FDA UDIEUDAMED
UI20 BS FDA 510(k)FDA UDIEUDAMED
UI20 MP FDA 510(k)FDA UDIEUDAMED
UI20 BL FDA 510(k)FDA UDIEUDAMED
UI20 PN FDA 510(k)FDA UDIEUDAMED
UI20 BR FDA 510(k)FDA UDIEUDAMED
UI20WG FDA 510(k)FDA UDIEUDAMED
UI20S WH FDA 510(k)FDA UDIEUDAMED
UI20S GR FDA 510(k)FDA UDIEUDAMED
UI20S BS FDA 510(k)FDA UDIEUDAMED
UI20S MP FDA 510(k)FDA UDIEUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)FDA UDI
Market of Registration
Austria EUDAMED
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDIFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

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 (30)

  • FDA 510(k) K241998 24 fields · synced Sep 18, 2026
  • FDA UDI 47caeab1-7d7c-4d28-bca9-85865ec40e5c 32 fields · synced May 26, 2026
  • FDA UDI 5e53e92e-6bc4-423a-848f-a312a1155277 32 fields · synced May 27, 2026
  • FDA UDI 8ee7a171-239b-4fc1-b5cf-4cf6bd927a74 32 fields · synced May 29, 2026
  • FDA UDI f46ebece-f62c-473e-9e92-2f14b8e4926c 32 fields · synced May 29, 2026
  • FDA UDI 63b81cc6-32f0-49ca-9eb2-7ffb7e163783 32 fields · synced May 30, 2026
  • FDA UDI ee0b28b3-b52a-4da7-b664-efe89db0dc5a 32 fields · synced May 30, 2026
  • FDA UDI 044e1ff3-9f68-451c-8bcf-72deda16b1c9 32 fields · synced May 30, 2026
  • FDA UDI 4a9d2de3-f839-4ec8-a6a0-d9aca18eb96c 32 fields · synced May 30, 2026
  • FDA UDI 9d4766f7-ea9e-4ac4-891a-84fc67e7d535 32 fields · synced May 30, 2026
  • FDA UDI c53c1c5f-e04d-4f4b-8fb6-082bf6fe7b22 32 fields · synced May 30, 2026
  • FDA UDI 7141f3d8-81c4-4858-926e-363e5bc49c2c 32 fields · synced May 30, 2026
  • FDA UDI ada16a8a-c009-4760-94d1-f54c59bad6a3 32 fields · synced May 30, 2026
  • EUDAMED 3fd959d4-ef5a-4e55-8c0d-adf5d85be6db 61 fields · synced Jul 8, 2026
  • EUDAMED e82863e6-2ed5-4e5f-b6a6-ff52ecca7bfc 61 fields · synced Jul 8, 2026
  • EUDAMED 8c619639-f606-4b2b-b408-feeed31d302b 61 fields · synced Jul 9, 2026
  • EUDAMED f7624afc-0378-4c60-8f1d-08a4fb0804fe 61 fields · synced Jul 10, 2026
  • EUDAMED 106966b2-8c3c-4631-bb12-fa724eb267d0 61 fields · synced Jul 13, 2026
  • EUDAMED 95d063fe-a7f7-40b0-b3bd-926341c97c76 61 fields · synced Jul 14, 2026
  • EUDAMED 9640f20e-0352-4072-b011-a4b7fc7a9a34 61 fields · synced Jul 15, 2026
  • EUDAMED acc2d0fb-5b3c-4c75-a295-48daec9e1a3e 61 fields · synced Jul 15, 2026
  • EUDAMED 845fa86c-d116-4871-8120-239567026ee8 61 fields · synced Jul 15, 2026
  • EUDAMED 037ae4f1-66f6-46c6-b15d-f4f09f031461 61 fields · synced Jul 21, 2026
  • EUDAMED 8abaab54-5610-4484-b774-a1b78be65e33 61 fields · synced Jul 23, 2026
  • EUDAMED 3d0c52a3-a116-4a3a-996e-f521494afbee 61 fields · synced Jul 23, 2026
  • EUDAMED 6f479a0a-3279-4cbc-9372-a15237d2803c 61 fields · synced Jul 25, 2026
  • EUDAMED 953bcf43-eb8f-443d-b365-c2a3976968bc 61 fields · synced Jul 26, 2026
  • EUDAMED a1bba2e5-be40-4ea5-9b7e-f2c1feeae642 61 fields · synced Jul 28, 2026
  • EUDAMED a1fb483f-92f9-4c42-99e9-91263998565a 61 fields · synced Jul 29, 2026
  • EUDAMED 974b025c-8f94-4609-a74e-1f537c45cf92 61 fields · synced Aug 3, 2026