Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
Device Facts
| Record ID | K251984 |
|---|---|
| Device Name | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) |
| Applicant | Shenzhen Ulike Smart Electronics Co., Ltd. |
| Product Code | OHT · General, Plastic Surgery |
| Decision Date | Jul 24, 2025 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 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.
Device Story
Over-the-counter, home-use IPL hair removal device; utilizes xenon arc flashlamp to emit intense pulsed light (550-1200nm) for hair reduction. Features sapphire treatment window for skin contact; integrated ice cooling function for user comfort. Device powered by external adapter; activation via finger switch. Includes skin sensor to prevent light emission unless in full contact with skin. Operates by delivering light pulses below skin surface to inhibit hair growth without cutting or pulling. User-operated; provides feedback via skin contact sensing. Benefits include nearly painless, heatless hair reduction. Intended for large and small body areas.
Clinical Evidence
Bench testing only. Evidence includes biocompatibility (ISO 10993-5, -10, -23), electrical safety/EMC (IEC 60601-1, -1-2, -1-11, -2-57, -2-83), photobiological safety (IEC 62471), and usability engineering (IEC 60601-1-6). Software verification and validation confirmed all requirements met and hazards mitigated.
Technological Characteristics
Xenon arc flashlamp IPL source; 550-1200nm wavelength; sapphire treatment window. Energy density 2.42-7.27 J/cm². Powered by external 100-240V AC adapter. Includes skin contact sensor and active ice cooling system. Microprocessor-controlled. Biocompatibility per ISO 10993. Electrical safety per IEC 60601 series. No sterilization required.
Indications for Use
Indicated for removal of unwanted hair and permanent reduction in hair regrowth in individuals with Fitzpatrick Skin Types I-V.
Regulatory Classification
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 (K250194)
- IPL Hair Removal Device (K230122)
- IPL Hair Removal Device (K221002)
Related Devices
- K250938 — Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) · Shenzhen Ulike Smart Electronics Co., Ltd. · May 23, 2025
- K241205 — Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE) · Shenzhen Ulike Smart Electronics Co., Ltd. · Sep 9, 2024
- K223618 — IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD · Shenzhen Ulike Smart Electronics Co., Ltd. · Feb 28, 2023
- K221002 — IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C · Shenzhen Ulike Smart Electronics Co., Ltd. · Jun 1, 2022
- K243085 — IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) · Zhuzhou Goldenhot Medical Technology Co., Ltd. · Dec 21, 2024
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
July 24, 2025
Shenzhen Ulike Smart Electronics Co., Ltd.
Yang Blue
Registration Director
810, Bldg 1, Xunmei Science and Tech Plaza, No. 8
Keyuan Rd, Science Pk Cmty Yuehai Sub-Dist. Nanshan Dist
Shenzhen, Guangdong 518000
China
Re: K251984
Trade/Device Name: Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
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: June 27, 2025
Received: June 27, 2025
Dear Yang Blue:
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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 systems (QS) regulation (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 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-
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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,
YAN FU -S
Digitally signed by YAN FU -S
Date: 2025.07.24 12:48:22
-04'00"
for 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 (8/23)
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: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251985 | |
| Device Name Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | |
| 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 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. | |
| 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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Shenzhen Ulike Smart Electronics Co., Ltd.
# 510(k) Summary of K251984
## 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: Blue Yang
Email: blue@ulike.com
The date the summary was prepared: 6/27/2025
## II. Device
Name of Device: Ice Cooling IPL Hair Removal Device
Model(s): UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU
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. 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) with safety and efficacy. It is designed with a lamp that can emit continuously double or triple pulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain and nearly heatless.
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Shenzhen Ulike Smart Electronics Co., Ltd.
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 be activated throughout the whole hair removal process to provide users with a more comfortable and safer experience.
# IV.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 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.
# V. Comparison of Technological Characteristics With the Predicate Device
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 IPL Hair Removal Device may be found substantially equivalent to its predicate devices.
Ice Cooling IPL Hair Removal Device is compared with the following legally marketed devices in terms of intended use, design, specifications and performance:
| Comparison Items | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Remark |
| --- | --- | --- | --- | --- | --- |
| 510(k) number | K251984 | K250194 | K230122 | K221002 | / |
| Trade Name | Ice Cooling IPL Hair Removal | Ice Cooling IPL Hair Removal | IPL Hair Removal Device | IPL Hair Removal Device | / |
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Shenzhen Ulike Smart Electronics Co., Ltd.
| | Device | Device | | | |
| --- | --- | --- | --- | --- | --- |
| Manufacturer | Shenzhen Ulike Smart Electronics Co., Ltd. | Shenzhen Ulike Smart Electronics Co., Ltd. | Shenzhen Ulike Smart Electronics Co., Ltd. | Shenzhen Ulike Smart Electronics Co., Ltd. | / |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | OHT | Same |
| Device classification | Class II | 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 permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of | 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 permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of | IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the 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 | IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the 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 | Same |
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Shenzhen Ulike Smart Electronics Co., Ltd.
| | hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. | hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. | completion of a treatment regime. | treatment regime. | |
| --- | --- | --- | --- | --- | --- |
| Prescription or OTC | OTC | OTC | OTC | OTC | Same |
| Applicable skin | Fitzpatrick Skin Types I-V | Fitzpatrick Skin Types I-V | Fitzpatrick Skin Types I-V | Fitzpatrick Skin Types I-V | 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) | 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) | Same |
| Device design | | | | | |
| Source energy | Supplied by external adapter | 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 | 100-240V~, 50/60Hz | Same |
| Dimension | 179.0*58.2*37.2m m | 179.0*58.2*37.2m m | 60×38×170mm | 60.5(W)x38(H)x169 . 7(L)mm | Same |
| Sterilization | Not required | Not required | Not required | Not required | Same |
| Output specification | | | | | |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
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Shenzhen Ulike Smart Electronics Co., Ltd.
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| --- | --- | --- | --- | --- | --- |
| Wavelength range | 550nm-1200nm | 550nm-1200nm | 560-1200mm | 550-1200mm | Same |
| Energy density | 2.42-7.27J/cm²
UI06S PR,UI06S PN,UI06S WH: 2.42-7.27J/cm²
UI06S PRU, UI06S PNU,UI06S WHU: 2.42-5.45J/cm² | 2.42-7.27J/cm² | 2.4-7.2J/cm² | 3.03-5.3J/cm² | Same |
| Output energy | 8-24J
UI06S PR,UI06S PN,UI06S WH: 8-24J
UI06S PRU, UI06S PNU,UI06S WHU: 8J~18J | 8-24J | 9.9~19.8J | 10.0~17.5J | Same |
| Spot size | 3.3cm² | 3.3cm² | 3.3cm² | 3.3cm² | Same |
| Pulse duration | 1.82-8.07ms
Multipulse
UI06S PR,UI06S | 1.82-8.07ms
multipulse | 1.15-6.2ms | 7-10ms | Same |
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Shenzhen Ulike Smart Electronics Co., Ltd.
| | PN,UI06S WH: 1.82-8.07ms
UI06S PRU, UI06S PNU,UI06S WHU: 1.82ms~7.09ms | | | | |
| --- | --- | --- | --- | --- | --- |
| Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch | Same |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue | Same |
| Output intensity level | 4 levels
UI06S PR,UI06S PN,UI06S WH: 4 levels
UI06S PRU, UI06S PNU,UI06S WHU: 3 levels | 4 levels | 5 Levels | 5 Levels | Same |
| Software/Firmware/Microprocess or Control? | Yes | Yes | Yes | Yes | Same |
| Additional features | | | | | |
| Electrical safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11 | ANSI AAMI ES 60601-1
IEC 60601-1-2 | ANSI AAMI ES 60601-1
IEC 60601-1-2 | Same |
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Shenzhen Ulike Smart Electronics Co., Ltd.
| | IEC 60601-2-57
IEC 60601-2-83 | IEC 60601-2-57
IEC 60601-2-83 | IEC 60601-1-11
IEC 60601-2-57
IEC 60601-2-83 | IEC 60601-1-11
IEC 60601-2-57
IEC 60601-2-83 | |
| --- | --- | --- | --- | --- | --- |
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | IEC 62471 | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | Same |
VIII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
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 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 Within a Risk Management Process, Document", as recognized 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
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Shenzhen Ulike Smart Electronics Co., Ltd.
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) Light 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
The product usability has been evaluated and validated according to the following standard and FDA guidance.
> IEC 60601-1-6:2005+2012+2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
> Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
Conclusion: Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Ice Cooling IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate devices.
