← Product Code [OHT](/productcode/OHT) · K260742

# Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) (K260742)

_Shenzhen Ulike Smart Electronics Co., Ltd. · OHT · May 5, 2026 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260742

## Device Facts

- **Applicant:** Shenzhen Ulike Smart Electronics Co., Ltd.
- **Product Code:** [OHT](/productcode/OHT.md)
- **Decision Date:** May 5, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the long-lasting reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

## Device Story

Over-the-counter, home-use IPL hair removal device; utilizes xenon arc flashlamp to emit light pulses; sapphire treatment window for skin contact; integrated ice cooling function for user comfort. Device requires external power adapter; activation via finger switch. Includes skin sensor to ensure full contact before light emission; prevents operation if contact is insufficient. User-operated for hair reduction on large (arms, legs, chest) and small (lip) areas. Output intensity adjustable (1-10 levels). Device provides non-invasive hair growth reduction; sapphire window and cooling system enhance user experience and safety. Healthcare provider does not operate; user follows treatment regime to achieve long-term hair reduction.

## Clinical Evidence

Bench testing only. No clinical trials performed. Evidence includes biocompatibility (ISO 10993-5, -10, -23), electrical safety/EMC (IEC 60601-1, -1-2, -1-11, -2-57, -2-83), photobiological eye safety (IEC 62471), software verification/validation, usability testing, and cleaning/disinfection validation (AAMI ST98, ASTM F3208).

## Technological Characteristics

IPL device using Xenon Arc Flashlamp; wavelength 550-1200nm; energy density 1.65-6.92 J/cm2; spot size 3.9cm2. Features sapphire treatment window, skin contact sensor, and integrated ice cooling. Powered by 100-240V external adapter. Microprocessor-controlled. Biocompatibility per ISO 10993; electrical safety per IEC 60601 series. Not sterile.

## Regulatory Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

## Predicate Devices

- Ice Cooling IPL Hair Removal Device ([K250942](/device/K250942.md))
- iPulse Hair Removal System ([K130315](/device/K130315.md))

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 5, 2026

Shenzhen Ulike Smart Electronics Co., Ltd.
Xue Dai
Regulatory Affairs Manager
810, Bldg. 1, Xunmei Science And Technology Plaza, # 8 Keyuan Rd., Science Park Community
Yuehai Sub-District, Nanshan District, Shenzhen 518000, Guangdong, P. R. China
Shenzhen,
China

Re: K260742
Trade/Device Name: Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: OHT
Dated: March 6, 2026
Received: March 6, 2026

Dear Xue Dai:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

TANISHA L. HITHE -S
Digitally signed by
TANISHA L. HITHE -S
Date: 2026.05.05 18:02:28
-04'00"

Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF

|  DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.  |
| --- | --- |
|  510(k) Number (if known) K260742  |   |
|  Device Name Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)  |   |
|  Indications for Use (Describe) Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the long-lasting reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.  |   |
|  Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C)  |   |
|  CONTINUE ON A SEPARATE PAGE IF NEEDED.  |   |
|  This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."  |   |
|  The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov  |   |
|  "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."  |   |

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# 510(k) Summary of K260742

# I. Submitter

Shenzhen Ulike Smart Electronics Co., Ltd.

Address:810, Building 1, Xunmei Science and Technology Plaza, No. 8 Keyuan Road, Science Park Community, Yuehai Sub-District, Nanshan District, Shenzhen 518000, Guangdong, P.R. China

Contact person: Dai Xue

Email: daixue@ulike.com

The date the summary was prepared: 04/15/2026

# II. Device

Name of Device: Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)

Common or Usual Name: Light Based Over-The-Counter Hair Removal

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: II

Product Code: OHT

Regulation Number: 21 CFR 878.4810

# III. Predicate Device

|  Predicate Device | Predicate Device 1 | Predicate Device 2  |
| --- | --- | --- |
|  510(k) number | K250942 | K130315  |
|  Trade Name | Ice Cooling IPL Hair Removal Device | iPulse Hair Removal System  |
|  Manufacturer | Shenzhen Ulike Smart Electronics Co., Ltd. | CyDen Ltd  |

# IV. Device Description

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with dual lamps that work together and can emit mutipulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain.

The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will

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be activated throughout the whole hair removal process to provide users with a more comfortable experience.

Ice Cooling IPL Hair Removal Device includes the following models: UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK. Their intended use, performance and operation are basically identical. The model difference is enclosure color.

# V. Indications for Use

Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the long-lasting reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

# VI. Comparison of Technological Characteristics With the Predicate Devices

The Ice Cooling IPL Hair Removal Device has the same intended use and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use. Therefore, the Ice Cooling IPL Hair Removal Device may be found substantially equivalent to its predicate devices.

Ice Cooling IPL Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, specifications and performance:

|  Comparison Items | K260742 | Predicate Device 1 | Predicate Device 2 | Remark  |
| --- | --- | --- | --- | --- |
|  510(k) number | / | K250942 | K130315 | /  |
|  Trade Name | Ice Cooling IPL Hair Removal Device | Ice Cooling IPL Hair Removal Device | iPulse Hair Removal System | /  |
|  Manufacturer | Shenzhen Ulike Smart Electronics Co., Ltd. | Shenzhen Ulike Smart Electronics Co., Ltd. | CyDen Ltd | /  |
|  Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same  |
|  Product code | OHT | OHT | OHT | Same  |
|  Device classification | Class II | Class II | Class II | Same  |
|  Indication for use/ Intended use | Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the | Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the | The iPulse Hair Removal System is an Over-the-counter device intended for the removal of unwanted hair. | Same  |

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|   | long-lasting reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. | permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. |  |   |
| --- | --- | --- | --- | --- |
|  Prescription or OTC | OTC | OTC | OTC | Same  |
|  Applicable skin | Fitzpatrick Skin Types I-V | Fitzpatrick Skin Types I-V | unknown | Same  |
|  Treatment area | Large areas (e.g. arms, legs, chest) and small areas (e.g. lip) | Large areas (e.g. arms, legs, chest) and small areas (e.g. lip) | leg, arm, bikini and underarm | Same  |
|  Device design  |   |   |   |   |
|  Source energy | Supplied by external adapter | Supplied by external adapter | Supplied by external adapter | Same  |
|  Power supply | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz | Same  |
|  Dimension | 206.73mm*68.68mm*54.29mm | 206.73mm*68.68mm*54.29mm | unknown | Same  |
|  Sterilization | Not required | Not required | Not required | Same  |
|  Output specification  |   |   |   |   |
|  Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same  |
|  Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same  |
|  Wavelength range | 550-1200mm | 550-1200mm | 530-1100nm | Same  |
|  Energy density | 1.65~6.92J/cm2 | 1.65~6.92J/cm2 | 7-10J/cm2 | Same  |
|  Output energy | 4.29~27J | 4.29~27J | 21~30J | Same  |
|  Spot size | 3.9cm2 | 3.9cm2 | 3cm2 | Same  |
|  Pulse duration | 0.88-6.35ms double pulse quadruple pulse | 0.86-6.32ms double pulse quadruple pulse | Variable - Single pulse 25 milliseconds. to Double Pulse 20ms on, 60 ms off. | SE Note 1  |
|  Pulsing control | Finger switch | Finger switch | Finger switch | Same  |
|  Delivery device | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue | Same  |

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Shenzhen Ulike Smart Electronics Co., Ltd.

|  Output intensity level | 1-10 Levels | 1-10 Levels | unknown | Same  |
| --- | --- | --- | --- | --- |
|  Software/Firmware /Microprocess or Control? | Yes | Yes | Yes | Same  |
|  skin pigmentation sensor | detect appropriate skin tones | detect appropriate skin tones | No | Same  |
|  Additional features  |   |   |   |   |
|  Electrical safety | IEC 60601-1 | IEC 60601-1 | unknown | Same  |
|   |  IEC 60601-1-2 | IEC 60601-1-2  |   |   |
|   |  IEC 60601-1-11 | IEC 60601-1-11  |   |   |
|   |  IEC 60601-2-57 | IEC 60601-2-57  |   |   |
|   |  IEC 60601-2-83 | IEC 60601-2-83  |   |   |
|  Eye safety | IEC 62471 | IEC 62471 | unknown | Same  |
|  Biocompatibility | ISO 10993-5 | ISO 10993-5 | unknown | Same  |
|   |  ISO 10993-10 | ISO 10993-10  |   |   |
|   |  ISO 10993-23 | ISO 10993-23  |   |   |

Note 1:

Although there is a minor difference of the pulse width between the subject device and predicate devices, it is within the pulse width value of the predicate devices. In addition, the subject device comply with IEC 60601-2-83 and IEC 62471 requirement, so this difference will not raise any safety or effectiveness issue.

Regarding the multipulse, the subject device operated on multipulse while the predicate device1 also operated on multipulse.

Regarding the multiple pulses at irregular pulse durations, the subject device operated on multipulse at irregular pulse durations while the predicate device 1 also operated on multipulse at irregular pulse durations.

Moreover, Temperature Test Report and Usability evaluation has been conducted to verify the users can use the device with multiple pulses safely and effectively, so such difference would not raise safety or effectiveness issue.

Summary of performance testing

The following performance data were provided in support of the substantial equivalence determination.

1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the Ice Cooling IPL Hair Removal Device was conducted in accordance with the "Use of International Standard ISO 10993- 1, 'Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing

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Within a Risk Management Process", as recommended by FDA. The following testing was performed to, and passed, including:

> ISO 10993-10:2021, Biological evaluation of medical devices Part 10: Tests for skin sensitization
> ISO 10993-23:2021, Biological evaluation of medical devices Part 23: Tests for irritation
> ISO 10993-5: 2009, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

## 2) Electrical Safety and EMC

Electrical safety and EMC testing was performed to, and passed, as per the following standards:

> IEC 60601-1:2005+A1:2012+A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
> IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
> IEC 60601-1-11:2015+A1:2020 Medical Electrical Equipment-Part 1-11: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
> IEC 60601-2-57:2011 Medical electrical equipment-Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
> IEC 60601-2-83:2022 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

## 3) Eye Safety

> IEC 62471:2006 Photobiological safety of lamps and lamp systems

## 4) Software Verification and Validation

Software documentation consistent with Basic Documentation Level was submitted in this 510(k). System testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

## 5) Usability

Usability test was conducted.

## 6) Cleaning & Disinfection Validation Test

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The cleaning & disinfection validation for reusable multi-patient use device has been conducted according to the following standard and FDA guidance:

> AAMI ST98-2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
> ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
> AAMI TIR12: 2020/(R)2023 Designing, Testing And Labeling Medical Devices Intended For Processing By Health Care Facilities: A Guide For Device Manufacturers

Conclusion: Based on the comparison analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate devices.

---

**Source:** [https://fda.innolitics.com/device/K260742](https://fda.innolitics.com/device/K260742)

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