(62 days)
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 is an oversonal device for har reduction by using Intense Pulsed Light (PL). It is designed with a lamp that can emit continuously double of this surface and does not involve any cuting or pulling, reducing har growth with nearly painless pain. The device is only powered by the external pover adapter activation is by finger switch. This product adopts spphire treatment window that is suitable for multiple hair removal areas. It contains a skin contact, if the device is not in full contact with the skin, the device canot emit the treatment light pulses. Besides, the device tunction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
The provided text is a 510(k) summary for the Ice Cooling IPL Hair Removal Device. It details the device's characteristics, comparison to predicate devices, and performance data submitted to support substantial equivalence.
However, the document does not contain the specific information requested regarding an AI/algorithm-based device, namely:
- Acceptance criteria table and reported device performance for an AI/algorithm. The document focuses on performance data for a non-AI medical device (biocompatibility, electrical safety, light safety, software verification, usability).
- Sample size and data provenance for a test set.
- Number of experts and qualifications for ground truth establishment.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Stand-alone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/algorithm.
- Sample size for the training set.
- How ground truth for the training set was established.
The device in question, an "Ice Cooling IPL Hair Removal Device," is regulated as a "Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology" (21 CFR 878.4810). While it mentions "Software Verification and Validation" and "Software documentation consistent with Basic Documentation Level," this typically refers to embedded software for device control and safety features, not a diagnostic or prognostic AI algorithm that processes image data to provide clinical insights, which would require the kind of performance study details requested in your prompt.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe a study involving an AI model for which such specific performance metrics and ground truth establishment details would be relevant.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 26, 2025
Shenzhen Ulike Smart Electronics Co.,Ltd. Blue Yang Registration Director 810. Building 1, Xunmei Science and Technology Plaza, No. 8 Keyuan Road, Science Park Community, Yuehai Sub-District Shenzhen, 518000 China
Re: K250194
Trade/Device Name: Ice Cooling IPL Hair Removal Device (U106S PR, U106S PN, U106S WH) 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: January 23, 2025 Received: January 23, 2025
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/cdrb/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
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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 System (OS) 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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Re"). 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-device-advicecomprehensive-regulatory-assistance/unique-device-identification-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for TANISHA L. HITHE -S. The signature was created on March 26, 2025 at 16:53:55 -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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Ice Cooling IPL Hair Removal Device (U106S PR, U106S PN, U106S WH)
Indications for Use (Describe)
lce 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary of K250194
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, Shezzher 518000, Guangdong, P.R. China Contact person: Blue Yang Email: blue@ulike.com The date the summary was prepared: 3/19/2025
II. Device
Name of Device: Ice Cooling IPL Hair Removal Device Model(s): UI06S PR, UI06S PN, UI06S WH 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. Legally Marketed Predicate Devices
| LegallyMarketedPredicate Devices | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 |
|---|---|---|---|
| 510(k) number | K242039 | K230122 | K221002 |
| Trade Name | Ice Cooling IPL Hair RemovalDevice | IPL Hair Removal Device | IPL Hair Removal Device |
| Manufacturer | Shenzhen Ulike Smart ElectronicsCo., Ltd. | Shenzhen Ulike SmartElectronics Co., Ltd. | Shenzhen Ulike Smart ElectronicsCo., Ltd. |
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| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
|---|---|---|---|
| Product code | OHT | OHT | OHT |
| Device classification | Class II | Class II | Class II |
IV. Device Description
Ice Cooling IPL Hair Removal Device is an oversonal device for har reduction by using Intense Pulsed Light (PL). It is designed with a lamp that can emit continuously double of this surface and does not involve any cuting or pulling, reducing har growth with nearly painless pain.
The device is only powered by the external pover adapter activation is by finger switch. This product adopts spphire treatment window that is suitable for multiple hair removal areas. It contains a skin contact, if the device is not in full contact with the skin, the device canot emit the treatment light pulses. Besides, the device tunction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
V. Indications for Use
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted 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.
VI. Comparison of Technological Characteristics with the Predicate Device
The Ice Cooling IPL Hair Removal Device has the similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate de no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent device. Ice Cooling IPL Hair Renoval Device is compared with the following legally marketed use, design, specifications and performance:
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| Comparison Items | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Remark |
|---|---|---|---|---|---|
| 510(k) number | / | K242039 | K230122 | K221002 | / |
| Trade Name | Ice Cooling IPL Hair Removal Device | Ice Cooling IPL Hair Removal Device | 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. | 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 |
| Deviceclassification | 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. | 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. | 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 | 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 | Same |
| stable reduction inthe number of hairsregrowing whenmeasured at 6, 9and 12 months afterthe completion of atreatment regime. | stable reduction inthe number of hairsregrowing whenmeasured at 6, 9and 12 months afterthe completion of atreatment regime. | measured at 6, 9and 12 months afterthe completion of atreatment regime. | measured at 6, 9 and12 months after thecompletion of atreatment regime. | ||
| Prescription orOTC | OTC | OTC | OTC | OTC | Same |
| Applicable skin | Fitzpatrick SkinTypes I-V | Fitzpatrick SkinTypes I-V | Fitzpatrick SkinTypes I-V | Fitzpatrick SkinTypes 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) andsmall areas (e.g. lip) | Same |
| Device design | |||||
| Source energy | Supplied byexternaladapter | Supplied byexternaladapter | Supplied byexternaladapter | Supplied by externaladapter | Same |
| Power supply | 100-240V~,50/60Hz | 100-240V~,50/60Hz | 100-240V~,50/60Hz | 100-240V~, 50/60Hz | Same |
| Dimension | 179.058.237.2mm | 206.73mm68.68mm54.29mm | 60×38×170mm | 60.5(W)x38(H)x169.7(L)mm | SE Note 1 |
| Sterilization | Not required | Not required | Not required | Not required | Same |
| Output specification | |||||
| Light source | Intense Pulsed | Intense Pulsed | Intense Pulsed | Intense Pulsed Light | Same |
| Light | Light | Light | |||
| Energy medium | XenonFlashlamp | Arc XenonFlashlamp | Arc XenonFlashlamp | Xenon Arc Flashlamp | Same |
| Wavelength range | 550nm-1200nm | 550-1200mm | 560-1200mm | 550-1200mm | Same |
| Energy density | 2.42-7.27J/cm² | 2.79J/cm2~6.41J/cm² | 2.4-7.2J/cm² | 3.03-5.3J/cm² | SENote 2 |
| Output energy | 8-24J | 10.9J~25J | 9.9~19.8J | 10.0~17.5J | SENote 3 |
| Spot size | 3.3cm² | 3.9cm² | 3.3cm² | 3.3cm² | Same |
| Pulse duration | 1.82-8.07msmultipulse | 0.93ms~3.50msmultipulse | 1.15-6.2ms | 7-10ms | SENote 4 |
| Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch | Same |
| Delivery device | Direct illuminationto tissue | Direct illuminationto tissue | Direct illuminationto tissue | Direct illumination totissue | Same |
| Outputintensitylevel | 4 levels | 1-10 Levels | 5 Levels | 5 Levels | SENote 5 |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | Yes | Same |
| Additional features | |||||
| Electrical safety | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | ANSI AAMI ES60601-1IEC 60601-1-2 | ANSI AAMI ES60601-1IEC 60601-1-2 | Same |
| IEC 60601-2-57IEC 60601-2-83 | IEC 60601-2-57IEC 60601-2-83 | IEC 60601-1-11IEC 60601-2-57IEC 60601-2-83 | IEC 60601-1-11IEC 60601-2-57IEC 60601-2-83 | ||
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | IEC 62471 | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | Same |
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Note 1:
The dimension belongs to basic characteristics. Although there is the direct and the predicate devices, but it will not affect the finction and intended use of the device, and they all comply with IEC 60601-1 requirements, so the difference will not raise sate.
Note 2:
Although there is a minor difference of the energy desicate devices, but the energy density of subject device is very similar to the value of the predicate device 2, and they all comply with IEC 60601-2-33 and IEC 62471 requirements, so such minor difference would not rase safety or effectiveness issue.
Note 3:
Although there is a minor difference of the subject device and predicate device, but the output energy of subject device is within the range of the value of the predicate device 1, and they all comply with IEC 60601-2-57/EC 60601-2-83 and IEC 62471 requirements, so such not raise safety or effectiveness issue.
Note 4:
Although there is a minor difference of the subject device and predicate devices, it is within the pulse width value of the predicate device 3. Regarding the multipulse, the subject device operated on multipulse. In addion, the subject device of addition, the subject device compy
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with IEC 60601-2-83 and IEC 62471 requirement, so this difference will not raise any safety or effectiveness issue.
Note 5:
Though the subject device has 4 energy levels, which is difference is insignificant and do not raise any safety or effectiveness problems.
VIII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the 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
- 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 equirements for basic safety and essental performance
IEC 60601-1-2:2014+A1:2020 Medical equipment - Part 1-2: General requirements for basic safety and essential performance - Ollateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1- 11:2015+A1:2020 Medical Equipment-Part 1- 11: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Systems Used in the Home Healthcare Environment
IEC 60601-2-57:2011 Medical electrical equirements 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 equipments for the basic safety and essettial performance of home light therapy equipment
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- Light Safety
IEC 62471:2006 Photobiological safety of lamps and lamp systems
- 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.
- Usability
The product usability has been evaluated according to the following standard and FDA guidance.
IEC 60601-1-6:2005+2012+2020 Medical electrical equirements 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-circuled 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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.