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: UI04 SD, UI04 DG), is an over-the-counter, home-use and personal 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 the spot size is 3.3cm² 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 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: UI04 SD, UI04 DG have the same indication for use, performance, structure design and operation, the only deference is their enclosure color (UI04 SD is Star White and UI04 DG is Dark Green).

AI/ML Overview

This document is a 510(k) summary for an IPL Hair Removal Device (models UI04 SD, UI04 DG). It outlines the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence.

Based on the provided text, the device in question is an IPL Hair Removal Device. The 510(k) submission primarily focuses on non-clinical performance data to support substantial equivalence, rather than a clinical study involving human readers or AI-assisted diagnostic performance. Therefore, many of the requested elements related to MRMC studies, ground truth establishment for AI, and expert adjudication are not applicable to this type of device and submission.

Here's an analysis of the acceptance criteria and performance as described in the document, focusing on the information that is present:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device's 510(k) clearance are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices through non-clinical performance testing related to safety and fundamental functionality. The document doesn't present specific quantitative performance metrics like sensitivity, specificity, or AUC, as would be typical for AI/diagnostic devices. Instead, the "performance" is demonstrated by meeting various safety and usability standards and having comparable technical characteristics to cleared predicates.

Acceptance Criteria Category	Reported Device Performance (Summary from Document)
Biocompatibility	All body-contacting components passed ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) tests, in accordance with FDA guidance.
Electrical Safety & EMC	Passed tests conforming to ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, and IEC 60601-2-83 standards. This indicates compliance with general safety, electromagnetic compatibility, home healthcare environment requirements, and particular requirements for non-laser aesthetic equipment and home light therapy equipment.
Eye Safety	Passed tests conforming to IEC 62471 (Photobiological safety of lamps and lamp systems).
Software V&V	Software documentation consistent with a "moderate level of concern" was submitted. System validation testing demonstrated that all software requirement specifications were met and all software hazards were mitigated to acceptable risk levels.
Usability	Product usability was evaluated and verified according to IEC 60601-1-6 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."
Functional Equivalence	The device has the "same intended use, mode of action and similar operational characteristics" as the predicate device and reference devices. Minor differences do not raise safety or efficacy issues. Key comparable technical specifications include: IPL light source, Xenon Arc Flashlamp energy medium, similar wavelength and energy density ranges, similar spot size, finger switch pulsing control, direct illumination, and 5 intensity levels.

Study That Proves the Device Meets Acceptance Criteria:

The "study" in this context is a series of non-clinical tests and a detailed comparison to predicate devices, rather than a clinical trial or an AI performance study as might be expected for diagnostic algorithms.

Sample size used for the test set and the data provenance:
- Test Set (for non-clinical validation): The document does not specify "sample sizes" in the way one would for patient data (e.g., number of patients or images). Instead, testing was performed on physical units of the device and its components to verify their compliance with various electrical, safety, biocompatibility, and usability standards. The number of devices or components tested is not specified but is assumed to be sufficient for standard regulatory compliance testing.
- Data Provenance: The testing appears to be conducted by the manufacturer or third-party labs on the device itself. The document implicitly suggests this is prospective testing done specifically for this submission. The country of origin of the data is not explicitly stated beyond the manufacturer being in Shenzhen, China.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission is for an IPL hair removal device, not an AI diagnostic device requiring expert interpretation of medical images or patient outcomes for ground truth. Ground truth in this context means compliance with engineering and safety standards, verified by testing according to those standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As there are no human readers interpreting data, an adjudication method is irrelevant. Test results against established standards (e.g., pass/fail for electrical safety tests) serve as the "ground truth."
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:
- No. An MRMC study was not conducted as this is not an AI-assisted diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not a standalone AI algorithm. The software mentioned is for controlling the device's functions, not for diagnostic or analytical purposes.
The type of ground truth used:
- For Biocompatibility: Positive/negative controls in in vitro cytotoxicity and skin sensitization tests, and adherence to ISO standards.
- For Electrical Safety/EMC/Eye Safety: Pass/fail criteria defined by the respective international standards (e.g., IEC 60601 series, IEC 62471).
- For Software V&V: Fulfillment of software requirement specifications and mitigation of identified software hazards.
- For Usability: Compliance with usability standards and FDA guidance on human factors, likely demonstrated through risk analysis and verification activities.
- For Functional Equivalence: Comparison of technical specifications (wavelength, energy density, etc.) against those of legally marketed predicate devices.
The sample size for the training set:
- Not Applicable. This device does not use an AI model trained on a data set in the typical sense (e.g., medical images for diagnosis). The term "training set" doesn't apply to the non-clinical performance and safety testing described.
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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

Re: K230122

Trade/Device Name: IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG 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 15, 2023 Received: January 17, 2023

Dear Riley Chen:

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); 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 medical devices and radiation-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.

Colin K. Chen -S

for

Jianting Wang Acting 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) K230122

Device Name IPL Hair Removal Device Model(s): UI04 SD, UI04 DG

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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

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

I. Submitter

Shenzhen Ulike Smart Electronics Co.,Ltd.

No.8, Keyuan Road, Yuehai Sub-district, Nanshan District, Shenzhen, Guangdong, China Post code: 518000 Tel.: +86 18600825411

Shane Xie Registration Director Tel: +86 18600825411 Email: Shane@ulikebeauty.com

II. Device

Name of Device: IPL Hair Removal Device Model(s): UI04 SD, UI04 DG 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

Predicate device:

Manufacturer	Reference Device	510(k) Number	Approval Date
Shen Zhen CosBeauty Co., Ltd	IPL Hair Removal DeviceJoy Version, CB-027	K173813	Sept. 07, 2018

Reference device:

Manufacturer	Reference Device	510(k) Number	Approval Date
Dongguan Define BeautyElectronic Technology Co.Ltd	IPL HAIR REMOVAL SG-8025	K212318	Jan.14, 2022

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IV. Device Description

V. Indications for Use

VI. Materials

Componentname	Material of Component	Body Contact Category	Contact Duration
IPL Hair RemovalDevice (Enclosureand treatmentwindow)	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 "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 and reference devices. Any minor differences between the subject device and the listed predicate devices and reference device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices and reference device for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices and reference device.

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

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ComparisonElements	Subject Device	Primary Device	Predicate Device	Reference Device	Remark
510(k)Number	Pending	K160968	K173813	K212318	/
Trade name	IPL Hair RemovalDevice	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 Hair RemovalDevice 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.	TheiPulse SmoothSkinGold Hair 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,only wordingdifference
Prescriptionor OTC	OTC	OTC	OTC	OTC	Same
Applicable	FitzpatrickSkin	Unknown	Fitzpatrick skin types I -	Unknown	Different
ComparisonElements	Subject Device	Primary Device	Predicate Device	Reference Device	Remark
skin	Types I-V		IV
Treatmentarea	large areas (e.g. arms,legs, chest) and smallareas (e.g. lip)	Unknown	Large areas (legs, arms,back and abdomen), face(upper lip, chin andsideburns)	Body and face	Similar
Device design
Sourceenergy	Supplied by externaladapter	External Powersupply	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	60mm x38mm x170mm	Unknown	12678200mm	2057656mm(HWD)	Different
Sterilization	Not required	Not required	Not required	Not required	Same
Output specification
Light source	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	Intense PulsedLight	Same
Energymedium	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon lamp	Same
Wavelengthrange	560-1200nm	510-1100nm	510-1200nm	530nm	Similar
Energydensity	2.4-7.2J/cm2	3-6J/cm2	1.8~5.1J/cm2	2.5J/cm2 Max	Similar
Outputenergy	9.9~19.8J	9~18J	Bodylampcartridge	11.77~22.21J510-1200nm	Level 1: 7.5JLevel 2: 8.5JLevel 3: 9.5JLevel 4: 11JLevel 5: 12J	Similar
			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	Similar
Pulseduration	1.15-6.2ms	2ms to 10ms	9.2~11.2ms	1ms	Different
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	Unknown	5	5	Same
ComparisonElements	Subject Device	PrimaryPredicateDevice	Predicate Device	Reference Device	Remark
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Yes	Same
Additional features
Electricalsafety	ANSIES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 60601-2-83	AAMIIEC 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 10993-10	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

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Shenzhen Ulike Smart Electronics Co.,Ltd. 510(k)s -Section 8. 510(k) Summary

Performance Data VIII.

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:

ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

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IEC 60601-1-11 Medical Electrical Equipment -Part 1-11: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
IEC 60601-2-57 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

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.