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: UI06 PL, UI06 PN, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD), 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 sapphire 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.

AI/ML Overview

The provided document is a 510(k) Summary for an IPL Hair Removal Device (K223618). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone clinical study with detailed acceptance criteria and performance metrics for the device's hair removal efficacy.

Therefore, the following information cannot be fully provided based on the given text:

A table of acceptance criteria and the reported device performance for hair removal efficacy: The document states the device is indicated for "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." However, it does not provide specific numerical acceptance criteria (e.g., "X% reduction in hair regrowth") or reported performance data from a primary efficacy study for the subject device. The comparison table (page 5) lists "Indication for use/Intended use" which is descriptive but not a performance metric.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) for hair removal efficacy: No information about a clinical study's test set for hair removal efficacy is provided.
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): This information would be relevant to a clinical study assessing efficacy, which is not detailed in the document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as a clinical efficacy study with ground truth adjudication is not described.
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 diagnostic tool that human readers would use.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc) for hair removal efficacy: Not detailed for hair removal efficacy.
The sample size for the training set: Not applicable, as this is not an AI/ML algorithm that requires a training set in the sense of predictive modeling.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on non-clinical performance data for safety (biocompatibility, electrical safety, EMC, eye safety), software verification, and usability. It concludes that the device is "as safe, as effective, and performs as well as the legally marketed predicate devices and reference device" based on a comparison of technological characteristics and these non-clinical tests.

Acceptance Criteria and Study Details (Based on available information)

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria for hair reduction efficacy are not provided in this document. The document primarily focuses on demonstrating safety and general performance equivalence to predicates through compliance with various standards.

Category	Acceptance Criteria	Reported Device Performance and Compliance
Hair Removal Efficacy	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 (This is the indication for use, not a specific numerical acceptance criterion provided for the subject device).	Not explicitly stated with primary data for the subject device. The statement is that the subject device has "the same intended use" and "similar operational characteristics" as predicate devices, and "Any minor differences... 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."
Biocompatibility	Compliance with ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) standards.	Passed ISO 10993-5:2009 and ISO 10993-10:2010.
Electrical Safety	Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, and IEC 60601-2-83 standards.	Passed all listed electrical safety and EMC standards.
Eye Safety	Compliance with IEC 62471 (Photobiological safety of lamps and lamp systems) standard.	Passed IEC 62471.
Software V&V	Software documentation consistent with moderate level of concern; all software requirement specifications met; all software hazards mitigated to acceptable risk levels.	All software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Usability	Evaluation and verification according to IEC 60601-1-6 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices".	The product usability has been evaluated and verified according to the listed standard and FDA guidance.

2. Sample size used for the test set and the data provenance (for hair removal efficacy)

Sample Size: Not specified in the provided document.
Data Provenance: Not specified in the provided document. The document relies on equivalence to previously cleared devices rather than providing primary clinical data for the subject device's efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as no clinical efficacy study with ground truth assessment is described for the submitted device.

4. Adjudication method for the test set

Not applicable.

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 diagnostic tool.

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

Not applicable.

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

For efficacy related to hair reduction, the document refers to the definition of permanent reduction (long-term, stable reduction in hair regrowth measured at 6, 9, and 12 months), but does not describe a study where this ground truth was established for the subject device. It hinges on the predicate devices having already met this.
For safety (biocompatibility, electrical safety, eye safety), the ground truth is established by meeting the specific requirements and passing the tests outlined in the referenced international standards (e.g., ISO 10993, IEC 60601 series, IEC 62471).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that learns from a training set. The "software" mentioned refers to embedded control software, not a machine learning model.

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

Not applicable.

Summary

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February 28, 2023

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, Oianhai Road Shenzhen, 518052 China

Re: K223618

Trade/Device Name: IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD 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: December 2, 2022 Received: December 5, 2022

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223618

Device Name IPL Hair Removal Device Model(s): UI06 PL, UI06 PN, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD

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

"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): U106 PL, U106 PN, U106 JL, U106 BR, U106 DB, U106 PR, U106 OG, U106 RD 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 SmoothSkinGoldHair Removal System	K160968	Apr.14, 2016

Predicate device:

Manufacturer	Predicate 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

The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable sapphire 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: UI06 PL, UI06 PN, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD have the same indication for use, performance, structure design and operation, the only deference is their enclosure color (UI06 PL is Purple, UI06 PN is Pink, UI06 JL is Yellow, UI06 BR is Brown, UI06 DB is Dark Brown, UI06 PR is Dark Purple, UI06 OG is Maple Red, UI06 RD is Red).

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 devices and reference device. 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

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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:

ComparisonElements	Subject Device	Primary PredicateDevice	Predicate Device	Reference Device	Remark
510(k)Number	K223618	K160968	K173813	K212318	/
Trade name	IPL Hair RemovalDevice	iPulseSmoothSkin Gold 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.	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 a	Same, in onlywording hairdifference
ComparisonElements	Subject Device	PrimaryDevice	Predicate Device	Reference Device	Remark
				treatment regimen.
Prescriptionor OTC	OTC	OTC	OTC	OTC	Same
Applicableskin	Fitzpatrick SkinTypes I-V	Unknown	Fitzpatrick skin types I - IV	Unknown	Different
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	58×34×179mm(W x H x D)	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	560-1200mm	510-1100nm	510-1200nm	530nm	Similar
Energydensity	3~6 J/cm²	3-6J/cm²	1.8~5.1J/cm²	2.5J/cm² Max	Similar
Outputenergy	9.9~19.8J	9~18J	Body lampcartridge	Level 1: 7.5JLevel 2: 8.5JLevel 3: 9.5JLevel 4: 11JLevel 5: 12J	Similar
			11.77~22.21J510-1200nm
			Facial lampcartridge3.65~~7.04J512-1197nmBikini lampcartridge3.84~~7.22J511-1200nm
Spot size	3.3cm²	3cm² (3cm by 1cm)	Body: 4.2cm²Bikini and face: 2.0cm²	3.0cm²	Similar
Pulseduration	1ms~7ms	2ms to 10ms	9.2~11.2ms	1ms	Similar
Pulsingcontrol	Finger switch	Finger switch	Finger switch	Finger switch	Same
ComparisonElements	Subject Device	Primary PredicateDevice	Predicate Device	Reference Device	Remark
Deliverydevice	Direct illumination to tissue	Direct illumination to tissue	Direct illumination to tissue	Direct illumination to tissue	Same
Outputintensity level	3	Unknown	5	5	Different
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Yes	Same
Additional features
Electricalsafety	ANSIES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 60601-2-83AAMI	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 10993-10	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

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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

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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
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 devices and reference device.

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 devices and reference device.

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.