Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION May 21, 2026 Shenzhen Ulike Smart Electronics Co., Ltd. Blue Yang Registration Director 810, Bldg. 1, Xunmei Science And Technology Plz., # 8 Keyuan Rd., Science Park Community Yuehai Sub-District, Nanshan District, Shenzhen 518000, Guangdong, P. R. China Shenzhen, China Re: K261325 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: April 21, 2026 Received: April 22, 2026 Dear Blue Yang: 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 {1} K261325 - Blue Yang Page 2 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 {2} K261325 - Blue Yang Page 3 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: 2026.05.21 00:02:15 -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 {3} 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) K261325 | | | 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." | | {4} Shenzhen Ulike Smart Electronics Co., Ltd. # 510(k) Summary K261325 ## 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: 05/07/2026 ## 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. 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 {5} Shenzhen Ulike Smart Electronics Co., Ltd. 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 | Predicate | Remark | | --- | --- | --- | --- | --- | | 510(k) number | K261325 | K250194 | K221002 | / | | Trade Name | Ice Cooling IPL Hair Removal Device | Ice Cooling IPL Hair Removal Device | IPL Hair Removal Device | / | | Manufacturer | 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 | 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 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. | 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. | 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 treatment regime. | Same | | Rx/ OTC | OTC | OTC | OTC | Same | {6} Shenzhen Ulike Smart Electronics Co., Ltd. | Applicable skin | 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) | Same | | 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 | | Dimensions, mm | 179.0×58.2×37.2 | 179.0×58.2×37.2 | 60.5(W)×38(H)×169.7(L) | Same | | Sterilization | Not required | Not required | Not required | Same | | 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 | 550nm-1200nm | 550nm-1200nm | 550-1200mm | Same | | Energy density | 2.42-7.27J/cm2UI06S PR,UI06S PN,UI06S WH: 2.42-7.27J/cm2UI06S PRU, UI06S PNU,UI06S WHU: 2.42-6.97J/cm2 | 2.42-7.27J/cm2 | 3.03-5.3J/cm2 | Same | | Output energy | 8-24JUI06S PR,UI06S PN,UI06S WH: 8-24JUI06S PRU, UI06S PNU,UI06S WHU: 8J~23J | 8-24J | 10.0~17.5J | Same | | Spot size | 3.3cm2 | 3.3cm2 | 3.3cm2 | Same | | Pulse duration | 1.82-8.07ms Multipulse UI06S PR,UI06S PN,UI06S WH: | 1.82-8.07ms multipulse | 7-10ms | Same | {7} Shenzhen Ulike Smart Electronics Co., Ltd. | | 1.82-8.07ms | | | | | --- | --- | --- | --- | --- | | | UI06S PRU, UI06S PNU,UI06S WHU: 1.82ms~8.07ms | | | | | Pulsing control | Finger switch | Finger switch | Finger switch | Same | | Delivery device | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue | Same | | Output intensity level | UI06S PR,UI06S PN,UI06S WH: 4 levels UI06S PRU, UI06S PNU,UI06S WHU: 3 levels | 4 levels | 5 Levels | this difference is insignificant and do not raise any safety or effectiveness problems. | | Software/Firmware/Microprocess or Control | Yes | Yes | Yes | Same | | Electrical safety | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-57 IEC 60601-2-83 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-57 IEC 60601-2-83 | ANSI AAMI ES 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-57 IEC 60601-2-83 | Same | | Eye safety | 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 | Same | | Modifications | 1. The software of UI06S PRU, UI06S PNU, UI06S WHU does not have previous Level 3 and changes the output energy of the maximum level from 24J into 23J. Moreover, the Strong Mode button of UI06S PRU, UI06S PNU, UI06S WHU is changed to the mode switch function. “a reusable single patient use device”changes into “a reusable multi-patient use device” | | | The changes haven’t raised any safety and effectiveness issues. SE | VIII. Performance Data 1) Software Verification and Validation Software documentation consistent with Basic Documentation Level was submitted in this {8} Shenzhen Ulike Smart Electronics Co., Ltd. 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. 2) Verification Report of Output Energy Density 3) Verification Report of Pulse Width 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.