(117 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 over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (PL). It is designed with clual lamps that work together and can emit single, continuously double or triple pulses per shot. It works below the sky cutting or pulling, reducing hair growth with nearly pain. It has three modes: Fast Mode, Normal Mode and High Mode. The device is only powered by the external pover adapter and its by finger switch. This product adopts sapplive treatment window that is suitable for multiple hair removal areas. It has 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 plas the ice cooling finction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
The provided text describes the regulatory filing for the "Ice Cooling IPL Hair Removal Device" and includes a comparison to predicate devices, but it does not contain information about a specific study proving the device meets acceptance criteria in the manner requested (e.g., clinical trial with performance metrics like sensitivity, specificity, accuracy, or effectiveness of AI assistance to human readers).
The document details:
- Indications for Use: Removal of unwanted hair and permanent reduction in hair regrowth (defined as reduction at 6, 9, and 12 months post-treatment regime).
- Comparison to Predicate Devices: A table comparing characteristics like regulation number, product code, light source, wavelength range, energy density, and pulse duration.
- Performance Data (Summary of performance testing): This section outlines bench testing and compliance with various international standards related to biocompatibility, electrical safety and EMC, light safety, software verification/validation, and usability. It does not include clinical efficacy data or performance metrics directly addressing the "permanent reduction in hair regrowth" claim.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance related to a clinical outcome.
- Sample size for a clinical test set or its provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for a clinical test set.
- MRMC study effect size.
- Standalone performance.
- Type of ground truth used for clinical effectiveness.
- Sample size for a clinical training set.
- How ground truth for a clinical training set was established.
The performance data summarized focuses on safety, electrical compliance, usability, and software testing, rather than a clinical study evaluating the device's hair removal efficacy against specific performance targets. The "conclusion" states the device "is as safe, as effective, and performs as well as the legally marketed predicate device," which is a statement of substantial equivalence based on the engineering and safety tests, and similarity to predicate devices, not on a new clinical effectiveness study presented in this summary.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. The word "ADMINISTRATION" is in a smaller font size than the other words.
November 6, 2024
Shenzhen Ulike Smart Electronics Co.,Ltd. Yang Blue Registration Director 810, Building 1, Xunmei Science and Technology Plaza, No. 8 Keyuan Road, Science Park Community, Yuehai Sub-District, Shenzhen, Guangdong 518000 China
Re: K242039
Trade/Device Name: Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) 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: July 12, 2024 Received: October 25, 2024
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/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.
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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.
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 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 (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 Rue"). 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical
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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-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,
Digitally signed by Yan Fu -S
Date: 2024.11.06 22:30:59
Yan Fu -S
-05'00'
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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Indications for Use
Submission Number (if known)
K242039
Device Name
lce Cooling IPL Hair Removal Device (UIM20 GR, UIM20 SL, UIM20 CB, UIM20 WR)
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)
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510(k) Summary of K242039
I. Submitter
Shenzhen Ulike Smart Electronics Co.,Ltd. Address810, Building 1, Xunmei Science and Technology Plaza, No. 8 Keyuan Road, Science Park Community, Yuehai Sub-District, Shenzhen 518000, Guangdong, P.R. China Contact person: Blue Yang Email: blue(@ulike.com The date the summary was prepared: 10/30/2024
II. Device
Name of Device: Ice Cooling IPL Hair Removal Device Model(s): UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR 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 (PL). It is designed with clual lamps that work together and can emit single, continuously double or triple pulses per shot. It works below the sky cutting or pulling, reducing hair growth with nearly pain. It has three modes: Fast Mode, Normal Mode and High Mode.
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The device is only powered by the external pover adapter and its by finger switch. This product adopts sapplive treatment window that is suitable for multiple hair removal areas. It has 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 plas the ice cooling finction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
IV.Indications for Use
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hars 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 minor differences between the subject device and the listed predicate device 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 as a ts predicate device.
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 | Reference Device 1 | Reference Device 2 | Reference Device 3 | Remark |
|---|---|---|---|---|---|---|
| 510(k) number | / | K230122 | K130315 | K230739 | K181121 | / |
| Trade Name | Ice Cooling IPL Hair Removal Device | IPL Hair Removal Device | iPulse Hair Removal System | Hand-held IPL device (IPL Home Use Hair Removal Device) | Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro | / |
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| Manufacturer | Shenzhen UlikeSmart ElectronicsCo., Ltd. | Shenzhen Ulike SmartElectronics Co., Ltd. | CyDen Ltd | Shenzhen IONKA MedicalTechnology Co., Ltd. | Home Well /Trading LTD | 6, 9 and 12 monthsafter thecompletion of atreatment regime. | reduction in thenumber of hairsre-growing whenmeasured at 6, 9,and12monthsafterthecompletionoftreatment regimen. | 2166852(mm) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Regulationnumber | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | PrescriptionorOTC | OTC | OTC | OTC | OTC | OTC | Same | Sterilization | Not required | Not required | Not required | Not required | unknown | Same |
| Product code | OHT | OHT | OHT | OHT | OHT, ONF | Same | Applicable skin | Fitzpatrick SkinTypes I-V | Fitzpatrick Skin TypesI-V | unknown | Fitzpatrick Skin Types I-V | unknown | Same | Light source | Intense PulsedLight | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense PulsedLight | Same |
| Deviceclassification | Class II | Class II | Class II | Class II | Class II | Same | Treatment area | Large areas (e.g.arms, legs, chest)and small areas(e.g. lip) | Large areas (e.g. arms,legs, chest) and smallareas (e.g. lip) | leg, arm, bikini andunderarm | unknown | unknown | Same | Energy medium | Xenon ArcFlashlamp | Xenon Arc Flashlamp | Xenon ArcFlashlamp | Xenon Arc Flashlamp | Xenon ArcFlashlamp | Same |
| Indication for use/Intended use | Ice Cooling IPLHair RemovalDevice withsapphire treatmentwindow isindicated for theremoval ofunwanted hair. Thedevice is alsoindicated for thepermanentreduction in hairregrowth, definedas the long-term,stable reduction inthe number ofhairs regrowingwhen measured at | IPL Hair RemovalDevice is indicated forthe removal ofunwanted hair. Thedevice is also indicatedfor the permanentreduction in hairregrowth, defined asthe long-term, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9 and12 months after thecompletion of atreatment regime. | The iPulse HairRemoval System isan Over-the-counterdevice intended forthe removal ofunwanted hair. | IPL Home Use HairRemoval Device isindicated for the removalof unwanted hair. Thedevice is also indicated forthe permanent reduction inhair regrowth, defined asthe long-term, stablereduction in the number ofhairs regrowing whenmeasured at 6, 9 and 12months after thecompletion of a treatmentregime. | The Beurer 5500IPL Device is anover the counterdevice intendedfor the removal ofunwanted bodyand/ or facial hairin adults. TheBeurer 5500 IPLDevice is alsointended forpermanentreduction inunwanted hair.Permanent hairreduction isdefined as along-term, stable | Same | Source energy | Suppliedbyexternaladapter | Supplied by externaladapter | Supplied by externaladapter | Supplied by externaladapter | unknown | Same | Wavelength range | 550-1200mm | 560-1200nm | 530-1100nm | 510nm~1200nm | 475 - 1200nm | SENote 2 |
| Power supply | 100-240V~,50/60Hz | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz | unknown | Same | Energy density | 2.79J/cm2~6.41J/cm2 | 2.4-7.2J/cm2 | 7-10J/cm2 | FZ-608, FZ-608G: 3.33 J/cm2FZ-100: 5.43 J/cm2FZ-200: 4.5 J/cm2 | 5J/cm2 | SENote 3 | |||||||
| Dimension | 206.73mm68.68mm54.29mm | 60mm x 38mm x170mm | unknown | FZ-608,FZ-608G:9814760(mm)FZ-100:1987144(mm)FZ-200: | unknown | SENote 1 | Output energy | 10.9J~25J | 9.9~19.8J | 21~30J | FZ-608, FZ-608G: Level 1:4.16J Level 2: 4.36J Level3: 5.1J Level 4: 6.1J Level5: 6.96J Level 6: 7.96JLevel 7: 8.63J Level 8:9.13JLevel 9: 10.0J | unknown | SENote 4 | |||||||
| Spot size | 3.9cm2 | 3.3cm2 | 3cm2 | 3.0cm2 | 3.0cm2 | SENote 5 | ||||||||||||||
| Pulse duration | 0.93ms~3.50msSingle pulseDouble pulseTriple pulse | 1.15-6.2ms | Variable -Single pulse25milliseconds.toDouble Pulse 20ms | 0.5~0.8 ms | unknown | SENote 6 |
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| on, 60 ms off. | ||||||
|---|---|---|---|---|---|---|
| Pulsing control | Finger switch | 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 | Direct illumination to tissue | Same |
| Output intensity level | 1-10 Levels | 5 Levels | unknown | FZ-608, FZ-608G: 9 levelsFZ-100: 9 levels FZ-200: 6 levels | unknown | SENote 7 |
| Software/Firmware/Microprocess or Control? | Yes | Yes | Yes | Yes | Yes | Same |
| skin pigmentation sensor | detect appropriate skin tones | No | No | No | detect appropriate skin tones | SENote 8 |
| Electrical safety | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 60601-2-83 | ANSI AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 60601-2-83 | unknown | ANSI AAMI ES60601-1IEC 60601-1-2 IEC60601-1-11 IEC60601-2-83 | unknown | Same |
| Eye safety | IEC 62471 | IEC 62471 | unknown | IEC 60601-2-57 | unknown | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-5ISO 10993-10 | unknown | ISO 10993-5ISO 10993-10 | unknown | Same |
Note 1:
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The dimension belongs to basic characteristics. Although there is the dimension device and the predicate device, 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 safety and effectiveness issue.
Note 2:
Although there is a minor difference of the wavelen the subject device, it is within the wavelength value of the predicate device and the reference devices the Maximum wavelength of the same as the predicate device, the Minimum wavelength of the subject device is lower than the predicate device but higher than the reference will not raise any safety or effectiveness ssue.
Note 3:
Although there is a minor difference of the energy dence and predicate device, but the energy density of subject device is within the range of the value of the predicate devices (the Maximum energy density of the subject device is lower than the predicate device but higher than the reference device 2, the Minimum energy density of the subject device is higher than the predicate device), and they all comply with IEC 60601-2-57/IEC 60601-2-83 and IEC 62471 requirements, so such minor difference would not raise safety or effectiveness issue.
Note 4:
Although there is a minor difference of the output energy between the subject device, but the output energy of subject device is within the range of the value of the predicate devices the Maximum output energy of the subject device is lower than the reference device 1 but higher than the predicate , the Minimum output energy of the subject than the reference device 2), and they all comply with IEC 60601-2-57/IEC 60601-2-83 and IEC 62471 requirements, so such minor difference would not raise safety or effectiveness issue.
Note 5:
There is minor difference in soot size between the rredicate device. The spot size is related to energy density and since the difference in energy density is not significant as explained in note 3, so this difference will not raise any safety or effectiveness issue.
Note 6:
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Although there is a minor difference of the pubject device and predicate device, it is within the pulse with value of the predicate device and the reference devices the Maximum pulse wice is lower than the predicate device but higher than the reference device 2, the Minimum pulse width of the subject device is higher than the reference 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, although the subject device on multipulse whereas the predicate device operated on a singular pulse, but the reference device 2 also operated on multipulse, and Temperature Test Report and Usability evaluation has been conducted to verify the users with multiple pulses safely and effectively, so such difference would not raise safety or effectiveness issue.
Note 7:
Though the subject device has 1-10 energy levels, which is difference is insignificant and do not raise any safety of effectiveness problems.
Note 8:
Although there is a difference of the skin pigmentation serves and predicate device, but the reference device 3 also has the skin pigmentation sensor to detect appropriate sking verified the skin tone detection module, so such difference would not raise safety or effectiveness issue.
Performance Data VIII.
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-contacts of the IPL Hair Removal Device was conducted in accordance with the "Use of
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International Standard ISO 1093- 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
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 essential performance
IEC 60601-1-2:2014+A1:2020 Medical 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 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 essental performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 60601-2-83:2019 Medical electrical equipments for the basic safety and essettial 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 this 510(k). System testing presented in this 510(k) demonstrated that all software requrement specifications are met and all software hazards have been mitigated to acceptable risk levels.
5) Usability
The product usability has been evaluated according to the following standard and FDA guidance.
EC 60601-1-6 Medical equipment - Part 1-6: General requirements for base safety and essential performance - Collateral standard: Usability
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Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
Conclusion: Based on the above analysis and non-concluded that the subject device IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device.
§ 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.