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.

Device Description

Ice Cooling IPL Hair Removal Device 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. This product emits light pulses and is designed to be suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device 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. The device includes a cooling function to cool the skin during the hair removal process to provide users with a more comfortable experience.

AI/ML Overview

The provided text is a 510(k) summary for the Shenzhen Ulike Smart Electronics Co., Ltd. Ice Cooling IPL Hair Removal Device. It describes the device, its intended use, and its comparison to predicate devices, along with performance testing. However, it does not contain the specific details about clinical study results, acceptance criteria, or the methodology that would be required to answer all the questions in the prompt.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for performance metrics related to hair removal (e.g., specific percentages of hair reduction deemed acceptable). It only mentions 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" as part of the Indications for Use.

The document does not report specific quantitative performance data for the hair reduction effectiveness of the device. Instead, it refers to "Performance data supports that the device is safe and as effective as the predicate devices for its intended use" as a general statement for substantial equivalence.

Therefore, for the specific request of a table of acceptance criteria and reported device performance related to the primary indication of hair removal, the necessary information is not present in the provided text.

The document does list standards and tests for safety and general performance, which implies that the device met the requirements of these standards. For example:

Acceptance Criteria (Implied by standard compliance)	Reported Device Performance (Implied by passing tests)
Biocompatibility standards (ISO 10993-5, -10, -23) are met.	Device passed biocompatibility testing.
Electrical safety standards (IEC 60601-1, -1-2, -1-11, -2-57, -2-83) are met.	Device passed electrical safety and EMC testing.
Light safety standard (IEC 62471) is met.	Device passed light safety testing.
Software requirements are met and hazards mitigated.	Software documentation submitted; system testing demonstrated specifications met and hazards mitigated.
Usability standard (IEC 60601-1-6) and FDA guidance for human factors are met.	Product usability evaluated and validated.

Missing Information:

The following information is not available in the provided text:

Sample size used for the test set and the data provenance: There is no mention of a clinical test set or the number of participants.
Number of experts used to establish the ground truth for the test set and qualifications: This information would be relevant for clinical studies, which are not detailed here.
Adjudication method for the test set: Not applicable as no clinical test set is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: This type of study is not mentioned. The device is a "home-use" device, so human-in-the-loop performance is not evaluated in the context of an MRMC study with AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the device functions autonomously for hair removal, the performance described is purely device-centric rather than an "algorithm only" evaluation in the context of diagnostic AI.
The type of ground truth used: As no clinical study results are detailed, no specific ground truth for hair removal efficacy is provided or referenced.
The sample size for the training set: Not applicable as this document does not describe the development or evaluation of an AI/ML training set.
How the ground truth for the training set was established: Not applicable.

Summary based on available info:

The document primarily focuses on establishing "substantial equivalence" to predicate devices through technical comparisons and compliance with relevant safety and performance standards (biocompatibility, electrical safety, light safety, software, usability). It asserts that performance data supports the device's safety and effectiveness, but it does not present the detailed clinical study design, results, or specific acceptance criteria for hair removal efficacy that would directly answer your questions about acceptance criteria and how a study proves it. For a medical device of this type, a clinical study would typically be conducted, and those results would contain the information you are requesting. This 510(k) summary only notes that such data was "provided in support of the substantial equivalence determination" but does not elaborate on the specific findings or methodology of that data.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 9, 2024

Shenzhen Ulike Smart Electronics Co., Ltd. Yang Blue Registration Director 810, Bldg 1,Xunmei Science and Technology Plaza,No. 8 Keyuan Rd., Science Park Community, Yuehai Sub-District, Nanshan Dis Shenzhen, China

Re: K241205

Trade/Device Name: Y6S GR, Y6S GA, Y6S GT, Y6S JU, Y6S MU, Y6S OG, Y6S CH, Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE 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: April 30, 2024 Received: April 30, 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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

{1}------------------------------------------------

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 Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

{2}------------------------------------------------

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,

TANISHA TANISHA L.HITHE -S L. HITHE - C Date: 2024.09.09

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

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K241205

Device Name

Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA, Y6S GT, Y6S JU, Y6S JM, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable):	Production Use (Part 21 CFR 601 Subpart D) Own-Tissue Standard (21 CFR 601 Subpart C)
--------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

|_ | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Shenzhen Ulike Smart Electronics Co., Ltd.

510(k) Summary of K241205

I. Submitter

Shenzhen Ulike Smart Electronics Co.,Ltd. Address:810, Building 1, Xunmei Science and Technology Plaza, No. 8 Keyuan Road, Science Park Community, Yuehai Sub-District, Nanshan District, Shenzhen 518000, Guangdong, P.R. China Contact person: Blue Yang Email: blue@ulike.com The date the summary was prepared: 09/08/2024

II. Device

Name of Device: Ice Cooling IPL Hair Removal Device Model(s): Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE 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

This product emits light pulses and is designed to be suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device 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. The device includes a cooling function to cool the skin during the hair removal process to provide users with a more comfortable experience.

{5}------------------------------------------------

Shenzhen Ulike Smart Electronics Co., Ltd.

IV.Indications for Use

V. Comparison of Technological Characteristics With the Predicate

Devices

The Ice Cooling IPL Hair Removal Device has the same intended use and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise new types of questions regarding safety and efficacy when the device is used for the indications for use stated above. Performance data supports that the device is safe and as effective as the predicate devices for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices.

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

Comparison Items	Subject Device	Predicate Device 1	Predicate Device 2
510(k) number	K241205	K221002	K240264
Trade Name	Ice Cooling IPL HairRemoval Device	IPL Hair RemovalDevice	Home use hairremoval device
Manufacturer	Shenzhen Ulike SmartElectronics Co., Ltd.	Shenzhen UlikeSmart ElectronicsCo., Ltd.	Shenzhen MlayIntelligentTechnology Co.,Ltd.
Regulation number	21 CFR 878.4810	21 CFR 878.4810	21 CFR878.4810
Product code	OHT	OHT	OHT
Deviceclassification	Class II	Class II	Class II
Indication for use/Intended use	Ice Cooling IPL HairRemoval Device withsapphire treatmentwindow is indicatedfor the removal ofunwanted hair. Thedevice is alsoindicated for thepermanent reduction	IPL Hair RemovalDevice is indicatedfor the removal ofunwanted hair. Thedevice is alsoindicated for thepermanentreduction in hairregrowth defined	The Home usehair removaldevice is anover-the-counterdevice intendedfor removal ofunwanted hairsuch as but notlimited to small

	in hair regrowth,	as the long-term,stable reduction in	areas such as
	defined as the	the number of hairs	underarm and
	long-term, stable	regrowing when	facial hair below
	reduction in the	measured at 6, 9	the chin line and
	number of hairs	and 12 months after	large areas such
	regrowing when	the completion of a	as legs, in
	measured at 6, 9 and	treatment regime.	patients with
	12 months after the		Fitzpatrick Skin
	completion of a		Phototypes I-V.
	treatment regime.
Prescription or	OTC	OTC	OTC
OTC
Applicable skin	Fitzpatrick Skin Types	Fitzpatrick Skin Types	Fitzpatrick Skin Types
	I-V	I-V	I-V
Treatment area	Large areas (e.g. arms,legs, chest) and small	Large areas (e.g.arms, legs, chest)and small areas	small areas suchas underarm andfacial hair belowthe chin line andlarge areas suchas legs
	areas (e.g. moustache)	(e.g. moustache)
Source energy	Supplied by externaladapter	Supplied byexternaladapter	Not known
Power supply	100-240V~, 50/60Hz	100-240V~,50/60Hz	Not known
Dimension	114×89×45mm	60.5(W)x38(H)x169.7(L)mm	Not known
Sterilization	Not required	Not required	Not required
Light source	Intense Pulsed Light	Intense PulsedLight	Intense PulsedLight
Energy medium	Xenon Arc Flashlamp	Xenon ArcFlashlamp	Xenon ArcFlashlamp
Wavelength range	550-1200nm	550-1200nm	510~1200nm
Energy density	$1.45J/cm^2$ ~ $5J/cm^2$	$3.03-5.3J/cm^2$	$1.37~5.23J/cm^2$
Output energy	4.35J~15J	10.0~17.5J	Not known
Spot size	$3.0cm^2$	$3.3cm^2$	$3.5cm^2$ , $3.9cm^2$
Pulse width	0.88~6.6ms	7-10ms	0.5~8.0ms
Pulsing control	Finger switch	Finger switch	Finger switch
Delivery device	Direct illumination totissue	Direct illuminationtotissue	Directillumination totissue
Output intensitylevel	3 Levels	5 Levels	Not known
Software/Firmware/	Yes	Yes	Yes

{6}------------------------------------------------

{7}------------------------------------------------

Microprocess orControl?
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	ANSI AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 60601-2-83
Eye safety	IEC 62471	IEC 62471	IEC 62471
Biocompatibility	ISO 10993-5ISO 10993-10ISO 10993-23	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10

Note 1:

Although there is a minor difference of the energy density range between the subject device and predicate devices, the maximum energy density of subject device is within the range of the value of the predicate devices and the difference is not considered to raise concerns regarding safety or effectiveness .

Note 2:

There are minor differences in spot sizes between the subject device and the predicate devices. Given that the maximum energy density and pulse width range of the subject device is within the range of the applicable predicate, the differences in spot sizes are not considered to raise concerns regarding safety and effectiveness.

Note 3:

Although there are difference in the pulse duration range between the subject device and predicate devices, the maximum and minimum pulse duration of subject device is within the range of the value of the applicable predicate device. Given the subject device's energy density, treatment window size, and other parameters, the difference in pulse duration range is not considered to raise concerns regarding safety and effectiveness.

Summary of performance testing

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the 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", 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

{8}------------------------------------------------

Shenzhen Ulike Smart Electronics Co., Ltd.

ISO 10993-23:2021, Biological evaluation of medical devices Part 23: Tests for irritation

ISO 10993-5: 2009, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

Electrical Safety and EMC

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

IEC 60601- 1:2005+A1:2012+A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601- 1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC 60601- 1- 11:2015+A1:2020 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 60601-2-57:2011 Medical electrical equipment-Part 2-57: Particular requirements basic safety and essential performance of non-laser source equipment intended for for the therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

IEC 60601-2-83:2019 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

Light Safetv

IEC 62471:2006 Photobiological safety of lamps and lamp systems

Software Verification and Validation

Software documentation consistent with Basic Documentation Level was submitted in this 510(k). System testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

Usability

The product usability has been evaluated and validated 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

Conclusion: The proposed device uses technology that is similar to the predicate device. The technology and design do not raise new types of questions regarding safety and effectiveness for the proposed indications for use, and the performance testing supports that the device can be used safely and effectively for the proposed indications for use. The proposed device is considered to be substantially equivalent to the predicate 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.