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.

Device Description

IPL Hair Removal Device (Model: UI04A, UI04B, UI04C), is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable treatment window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). 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 cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

AI/ML Overview

The provided text is a 510(k) Summary for an IPL Hair Removal Device. It details the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain a study proving the device meets specific acceptance criteria related to its primary intended use (hair removal/reduction effectiveness). The "Performance Data" section focuses on safety and regulatory compliance aspects, not clinical performance for efficacy.

Therefore, many of the requested items cannot be extracted from the provided text.

Here is an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific acceptance criteria or reported device performance for hair removal efficacy. The "Performance Data" section focuses on demonstrating compliance with safety standards and biocompatibility.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in the document. The document refers to "usability evaluation has been conducted to verify these skin types can use the device safely and effectively," but does not detail the study design, sample size, or data provenance for this evaluation, nor does it provide the results for hair removal efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an IPL hair removal device, not an AI-assisted diagnostic tool that would typically involve a multi-reader, multi-case study for diagnostic accuracy.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the device itself. While there is no detailed efficacy study presented, the statement "usability evaluation has been conducted to verify these skin types can use the device safely and effectively" implies some form of standalone evaluation was performed. However, the details of what was measured for "effectively" in terms of hair reduction are missing, as are the quantitative results.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated for efficacy outcomes. For safety evaluations (biocompatibility, electrical safety, eye safety), the ground truth is established by adherence to recognized international standards and passing criteria within those standards. For the usability evaluation, the "ground truth" would likely be subjective user feedback and expert observation, but no details are provided.

8. The sample size for the training set

Not provided, as this is not an AI/algorithm training scenario as commonly understood for this question.

9. How the ground truth for the training set was established

Not applicable for a training set in this context.

Summary

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Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 1, 2022

Shenzhen Ulike Smart Electronics Co.,Ltd % Tracy Che Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90. Oianhai Road Shenzhen, Guangdong 518052 China

Re: K221002

Trade/Device Name: IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHT Dated: March 22, 2022 Received: April 4, 2022

Dear Tracy Che:

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 (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 located 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.

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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 and Part 809: medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221002

Device Name IPL Hair Removal Device Model(s): UI04A, UI04B, UI04C

Indications for Use (Describe)

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 K221002

"510(k) Summary" as required by 21 CFR Part 807.92.

I. Submitter

Shenzhen Ulike Smart Electronics Co.,Ltd

No.8, Keyuan Road, Yuehai Subb-district, Nanshan District, Shenzhen, Guangdong, China Post code: 518000 Tel.: +86 15915373017

Xiaoming Lin Regulation Manager Tel: +86 15915373017 Email: rd5(@ulikebeauty.com

II. Device

Name of Device: IPL Hair Removal Device Model(s): UI04A, UI04B, UI04C Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810

III. Predicate Device

Primary predicate device:

Manufacturer	Predicate Device	510(k) Number	Approval Date
CyDen Limited.	iPulse SmoothSkin GoldHair Removal System	K160968	Apr.14, 2016

Reference devices:

Manufacturer	Reference Device	510(k) Number	Approval Date
Shen Zhen CosBeauty Co., Ltd	IPL Hair Removal DeviceJoy Version, CB-027	K173813	Sept. 07, 2018
Dongguan Define BeautyElectronic Technology Co.Ltd	IPL HAIR REMOVAL SG-8025	K212318	Jan.14, 2022

IV. Device Description

IPL Hair Removal Device (Model: UI04A, UI04B, UI04C), is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). It works below

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the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable treatment window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). 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 cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

IPL Hair Removal Device, model: UI04A, UI04B, UI04C have the same indication for use, performance, structure design and operation, the only deference is their enclosure color (UI04A is white, UI04B is mint green and UI04C is deep green).

V. Indications for Use

VI. Materials

Componentname	Material of Component	Body Contact Category	Contact Duration
IPL HairRemoval Device(Enclosure andtreatmentwindow)	ABS, PC,Crystal application	Surface-contactingdevice: Intact skin	Less than 24 hours

We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section 16 "Biocompatibility Discussion".

VII.Comparison of Technological Characteristics With the Predicate Device

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

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

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ComparisonElements	Subject Device	Predicate Device	Reference Device 1	Reference Device 2	Remark
510(k)Number	Pending	K160968	K173813	K212318	/
Trade name	IPL Hair RemovalDevice (UI04A,UI04B, UI04C)	iPulse SmoothSkinGold Hair RemovalSystem	IPL Hair RemovalDevice Joy Version, CB-027	IPL HAIRREMOVAL SG-/8025	/
Manufacturer	Shenzhen UlikeSmart ElectronicsCo.,Ltd	Cyden Limited.	Shen Zhen CosBeautyCo., Ltd	Dongguan DefineBeauty ElectronicTechnology Co.Ltd	/
Regulationnumber	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	Same
Product code	OHT	OHT, GEX	OHT	OHT	Same
Deviceclassification	Class II	Class II	Class II	Class II	Same
Indication foruse/ Intendeduse	IPL HairRemovalDevice is indicatedfor the removal ofunwanted hair. Thedevice is alsoindicated for thepermanent reductionin hair regrowth,defined as the long-term, stable reductionin the number of hairsregrowing whenmeasured at 6, 9 and12 months after thecompletion of atreatment regime.	TheiPulseSmoothSkin GoldHair Removal Systemis indicated for theremoval of unwantedhair. The iPulseSmoothskin Gold isalso indicated for thepermanent reductionin hair regrowth,defined as the long-term, stable reductionin the number of hairsregrowing whenmeasured at 6, 9 and12 months after thecompletion of atreatment regime.	The IPL Hair RemovalDevice Joy Version isindicated for theremoval of unwantedhair. The device is alsoindicated for thepermanent reduction inhair regrowth, definedas the long-term, stablereduction in the numberof hairs regrowing whenmeasured at 6, 9 and 12months after thecompletion of atreatment regime. Thedevice is used for adultswith Fitzpatrick skintypes I - IV.	The IPL HairRemoval (Model:SG-8025) is anover the Counterdevice intended forthe removal ofunwanted bodyand/or facial hairin adults. It is alsointended forpermanentreduction inunwanted hair.Permanent hairreduction isdefined as thelong-term stablereduction in thenumber of hairs re-growing whenmeasured at 6. 9.and 12 monthsafter thecompletion of atreatment regimen.	Same, onlywordingdifference
Prescriptionor OTC	OTC	OTC	OTC	OTC	Same
Applicable	FitzpatrickSkin	Unknown	Fitzpatrick skin types I -	Unknown	Different
ComparisonElements	Subject Device	Predicate Device	Reference Device 1	Reference Device 2	Remark
skin	Types I-V		IV		Note 1
Treatmentarea	large areas (e.g. arms,legs, chest) and smallareas (e.g. fingers,lip)	Unknown	Large areas (legs, arms,back and abdomen), face(upper lip, chin andsideburns)	Body and face	Similar
Device design
Sourceenergy	Supplied by externaladapter	ExternalPowersupply	Supplied by externaladapter	Supplied byexternal adapter	Same
Power supply	100-240V~, 50/60Hz	110V or 230V,50/60Hz	100-240 VAC, 50/60Hz	Unknown	Same
Dimension	60.5(W)x38(H)x169.7(L)mm	Unknown	12678200mm	2057656mm(HWD)	DifferentNote 2
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
Energymedium	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon lamp	Same
Wavelengthrange	550-1200mm	510-1100nm	510-1200nm	530nm	SimilarNote 3
Energydensity	$3.03-5.3J/cm^2$	$3-6J/cm^2$	$1.8~5.1J/cm^2$	$2.5J/cm^2$	SimilarNote 4
Outputenergy	$10.0~17.5J$	$9~18J$	Bodylampcartridge	11.77~~22.21J510~~1200nm	Level 1: 7.5JLevel 2: 8.5JLevel 3: 9.5JLevel 4: 11JLevel 5: 12J	SimilarNote 4
			Faciallampcartridge	3.65~~7.04J512~~1197nm
			Bikinilampcartridge	3.84~~7.22J511~~1200nm
Spot size	3.3cm²	3cm² (3cm by 1cm)	Body: 4.2cm²Bikini and face: 2.0cm²	3.0cm²	SimilarNote 5
Pulseduration	7-10ms	2ms to 10ms	9.20~11.20ms	1ms	SimilarNote 6
Pulsingcontrol	Finger switch	Finger switch	Finger switch	Finger switch	Same
Deliverydevice	Direct illumination totissue	Direct illumination totissue	Direct illumination totissue	Direct illuminationto tissue	Same
Outputintensity level	5 Levels	Unknown	5 levels	5 levels	Same
ComparisonElements	Subject Device	Predicate Device	Reference Device 1	Reference Device2	Remark
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Yes	Same
Additional features
Electricalsafety	IEC 60601-1-2IEC 60601-1-11ANSIAAMIES60601-1IEC 60601-2-57IEC 60601-2-83	IEC 60601-1IEC 60601-1-2IEC 60601-2-57	IEC 60601-1IEC 60601-1-2IEC 60601-2-57	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57	Similar
Eye safety	IEC 62471	IEC 62471	Unknown	IEC 62471	Same
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10ISO 10993-12	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

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Note 1:

Though the applicable skin tone type is different from the reference devices, the commonly recognized applicable skin tone types for IPL hair removal device is mostly Fitzpatrick skin types I-IV or I-V. The applicable skin tone types of the subject device is Fitzpatrick skin types I-V and usability evaluation has been conducted to verify these skin types can use the device safely and effectively, so this difference will not raise any safety/ effectiveness problems.

Note 2:

Though the dimension is different from the predicate device and reference devices, this difference is insignificant and do not raise any safety/ effectiveness problems.

Note 3:

Though the wavelength of subject device is a little different from the predicate device, it's within the range of reference device 1, and they all comply with IEC 60601-2-57/IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.

Note 4:

Though the energy density and the output energy of subject device is a little different from the predicate device and reference devices, the energy density and the output energy of subject device is within the range of the minimum and maximum value of the predicate device and reference devices, and they all comply with IEC 60601-2-57/IEC 60601-2-83 and IEC 62471 requirement, so this difference will not raise any safety or effectiveness issue.

Note 5:

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There is minor difference in spot size between the subject device and the predicate device. The spot size is related to energy density and since the difference in energy density is not significant as explained in note 4, so this difference will not raise any safety or effectiveness issue.

Note 6:

Though the pulse duration of subject device is a little different from the predicate device, it's basically within the range of the predicate and reference devices, and the subject device comply with IEC 60601-2-57/IEC 60601-2-83 and IEC 62471 requirement, so this difference will not raise any safety or effectiveness issue.

VIII. Performance Data

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 Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:

ISO 10993-5:2009, Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization

2) Electrical Safety and EMC

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

IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-11 Medical Electrical Equipment -Part 1: 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 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 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

3) Eye Safety

IEC 62471 Photobiological safety of lamps and lamp systems

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4) Software Verification and Validation

Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation 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 verified according to the following standard and FDA guidance

IEC 60601-1-6 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

Summary

Based on the above performance as documented in this application, IPL Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device and reference devices.

IX. Conclusions

Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device and reference devices.

Regulation Number and Section

§ 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.