The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It is also intended for permanent reduction in unwanted hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen.

Device Description

IPL Salon Hair Reduction System, Model: F60001, a small over-the-counter device, is a homeuse device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). Emission activation is by finger switch. Device includes a treatment window head, a facial adaptor and battery charger/AC cord. It is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 650g, and the size is 143 x69.5 x 43mm (HWD).The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.

AI/ML Overview

The provided text details a 510(k) premarket notification for the "IPL Salon Hair Reduction System." It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparisons of technical specifications.

However, there is explicitly no clinical testing performed for this device.
Therefore, the document does not contain information on acceptance criteria for device performance based on a clinical study, reported device performance from such a study, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training data. These elements are typically found in clinical study reports, which are absent here.

The document states:

"No clinical testing was performed" (page 9).

This means the request to describe the acceptance criteria and study that proves the device meets acceptance criteria based on clinical performance cannot be fulfilled from the provided text. The submission relies on demonstrating substantial equivalence through non-clinical tests (electrical safety, EMC, software V&V, biocompatibility, usability) and comparison of technological characteristics with predicate devices.

Therefore, the only 'acceptance criteria' implicitly conveyed are adherence to applicable safety standards and similarity in technical specifications to legally marketed devices.

Here's what can be extracted based on the provided text, focusing on the non-clinical aspects and the lack of clinical study data:

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

Acceptance Criteria: Based on the information provided, the "acceptance criteria" are not quantitative performance metrics from a clinical study for hair reduction efficiency or safety endpoints (e.g., specific percentage of hair reduction, or complication rates). Instead, they are defined by compliance with recognized safety and performance standards for medical devices and demonstration of substantial equivalence to predicate devices in terms of technical characteristics and intended use.
- Compliance with IEC 60601-1 (Electrical safety)
- Compliance with IEC 60601-1-2 (Electromagnetic compatibility)
- Compliance with IEC 60601-2-57 (Specific requirements for light sources for aesthetic and therapeutic applications)
- Compliance with FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices" (Software V&V)
- Compliance with ISO 10993-5 (Biocompatibility - cytotoxicity)
- Compliance with ISO 10993-10 (Biocompatibility - irritation and skin sensitization)
- Usability as intended.
- Technical specifications (e.g., wavelength, Max Fluence) within comparable ranges or not raising new safety/effectiveness concerns compared to predicate devices.
Reported Device Performance: The document only reports the results of non-clinical tests indicating compliance with the above standards and the device's technical specifications. It does not provide performance metrics related to hair reduction efficacy or safety from a clinical perspective.

Acceptance Criteria (Type)	Reported Device Performance (Compliance/Specification)
Electrical Safety (IEC 60601-1, IEC 60601-2-57)	"Electrical safety test according to IEC 60601-1 and IEC 60601-2-57 standards" (Passed). "Patient leakage current: Comply with IEC 60601-1" (Complies).
Electromagnetic Compatibility (EMC) (IEC 60601-1-2)	"Electromagnetic compatibility test according to IEC 60601-1-2 standard" (Passed).
Software Verification and Validation (FDA Guidance)	"Software verification and validation test according to the requirements of the FDA 'Guidance for PreMarket Submissions and for Software Contained in Medical Devices'" (Passed).
Biocompatibility (ISO 10993-5, ISO 10993-10)	"Biocompatibility test according to ISO10993-5 and ISO10993-10" (Passed). "Relevant biocompatibility evaluations were performed and tests reports are provided to claim substantial equivalence." "All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements."
Usability	"Usability study testing shown that the device can be used as intended."
Technical Specifications (e.g., Wavelength, Max Fluence, Pulse Duration)	Wavelength: 475nm~1200nm (within predicate range). Max Fluence: Up to 5 J/cm² (comparable to predicates, specifically less than reference predicate's 10 J/cm²). Pulse duration: 11-12 ms (comparable to primary predicate's 11-13ms). Spot Size: 1.72 cm² or 3.02 cm² (minor difference, deemed not to raise safety/effectiveness issues). Output Intensity Level: 5 levels. Max number of Flashes: 150,000 times. Non-continuous operation: 1min on / 3min off.
Safety (No new safety/effectiveness issues compared to predicate devices due to differences)	All differences (Power Source, Weight, Dimensions, Max. Fluence, Wavelength, Spot Size) were evaluated and deemed not to "raise any safety or effectiveness issue" compared to the predicate devices, as they comply with relevant IEC standards.

Regarding the device's efficacy for "permanent hair reduction":
The document states the device's intention for "permanent reduction in unwanted hair," defined as "the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen." However, no clinical study data is provided in this submission to demonstrate that the device achieves this stated efficacy. The 510(k) process allows for substantial equivalence claims based on non-clinical data if the device is sufficiently similar to legally marketed predicate devices.

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

Not applicable for clinical efficacy studies. No clinical test set data is provided as no clinical testing was performed.
For non-clinical tests (e.g., electrical safety, EMC, biocompatibility), the "sample size" refers to the number of devices or components tested to demonstrate compliance. This is typically one or a few units as required by standards, not a patient sample. The provenance of such lab testing data would be the testing laboratories, likely in China or an accredited international lab.

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 applicable. No clinical test set where "ground truth" related to hair reduction efficacy or side effects would be established by experts.

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

Not applicable. No clinical test set requiring adjudication.

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 reduction system, not an AI diagnostic imaging tool or a system requiring human interpretation with AI assistance. No MRMC study was conducted.

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

Not applicable. This is a hardware device; no standalone algorithm performance was assessed as part of this submission. The "Software/Firmware/Microprocessor Control?" states "Yes," and "Software verification and validation test" was performed, but this refers to the internal operating software of the device itself, not a separate diagnostic algorithm.

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

Not applicable for clinical efficacy. For non-clinical tests, "ground truth" relates to compliance with standard specifications (e.g., electrical parameters must be within a defined range, materials must not elicit a cytotoxic response). The ground truth is the standard's defined acceptance limits.

8. The sample size for the training set

Not applicable. No machine learning model or "training set" for clinical data was used or described in this submission.

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

Not applicable. (See point 8).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.

September 11, 2018 Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt % Iris Fung PM SGS-CSTC Standards Technical Services Co., Ltd. 108 Kezhu Road Scientech Park Guangzhou Economic & Technology Dept Guangzhou. CN

Re: K181568

Trade/Device Name: IPL Salon Hair Reduction System 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: June 10, 2018 Received: June 14, 2018

Dear Iris Fung:

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/ofdocs/ofpmn.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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181568

Device Name

IPL Salon Hair Reduction System

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

Date of the summary prepared: September 8, 2018

510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

Applicant

� Company Name: Medical Device Branch of Zhangzhou Easepal Industrial Co.,Ltd.
Address: 4th Floor of Building #1, No.228, Jiaosong Road, Taiwanese Investment Zone, � Zhangzhou, Fujian, China.
Phone: +86 1366 609 7743 �
� Fax:+86 059 6626 8816
� Contact Person (including title): Bruce Wu
E-mail: brucewu@easepal.com.cn �

Application Correspondent:

SGS-CSTC Standards Technical Services Co., Ltd. �
Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology �

Development

District, Guangzhou, Guangdong, CHINA

� Contact Person: Ms. Iris Fung
Tel: +86-20-32136908 �
Email: Iris.Fung@sgs.com �

2. Subject Device Information

Trade Name: � IPL Salon Hair Reduction System
IPL Salon Hair Reduction System Common Name: �
Light Based Over-The-Counter Hair Removal Classification name: �
General & Plastic Surgery Review Panel: �
ОНТ � Product Code:
Regulation Class: 2 �
878.4810 Regulation Number: �

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3. Predicate Device Information

Predicate Type	Primary Predicate Device	Reference Predicate Device
510(k) Number	K161428	K140631
Regulation Number	878.4810	878.4810
Product Code	OHT	ONF
Device Name	PerfectSmooth	Lumena FH Hair Removal System
Sponsor	Shen Zhen CosBeauty Co., Ltd.	Shaser, Inc.

2. Device Description

5. Intended Use / Indications for Use

The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6. 9. and 12 months after the completion of a treatment regimen.

6. Design

A flash of Intense Pulsed Light (IPL) is directed at the skin and the light energy travels along the pigment in the hair, where it is converted to heat energy. It is the heat energy that disables the hair follicle preventing the hair from regrowing. Treated hairs will shed naturally within a couple of weeks of treatment and will not regrow. Each treatment will only be effective on hairs that are in their active growth phase at the time, so it is important to follow a course of treatments over a twelve-week period to ensure all hairs are treated.

The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered. The device is designed for use on the legs, underarms, bikini line, chest, stomach, back, arms and on the face below the cheekbones [although not recommended for use on male facial hair].

7. Materials

Listed below is the material that comes in contact with the user.

Component of	Material of	Body Contact	Contact Duration
--------------	-------------	--------------	------------------

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Device RequiringBiocompatibility	Component	Category(ISO 10993-1)	(ISO 10993-1)
IPL Lamp outputwindow	ABS	Surface-contactingdevice: skin	Maximum 30minutes(< 24hours)

Relevant biocompatibility evaluations were performed and tests reports are provided to claim substantial equivalence.

8. Physical characteristics

Basic Unit Characteristics
Compliance* with 21 CFR 898	N/A
Main Unit Weight	650g
Main Unit Dimension	14369.543mm(HWD)
Housing Materials of main unit	PC2805
Indicator	Indicates power information, intensity levelinformation.
Environment for operation	Temperature: 10°C~35°CHumidity: 3%~~75%Pressure: 700~~1060hPa
Storage and Transport Conditions	Temperature: -35°C~70°CHumidity: 10%~~90%Pressure: 500~~1060hPa
Compliance with VoluntaryStandards	Yes, Comply with IEC 60601-1, IEC 60601-1-2,IEC 60601-2-57,
Patient leakage current	Comply with IEC 60601-1
Power Source	Supplied by external adapter
Software/Firmware/MicroprocessorControl?	Yes
Specification
Output Intensity Level	5
Output energy with facial adaptor	Level 1: 8.62JLevel 2: 9.45JLevel 3: 10.64JLevel 4: 11.48JLevel 5: 12.70J
Emitted Light Spectrum	475nm~1200nm Max
Max Energy density:	Up to 5 J/cm²
Treatment Area (regular window)	3.025 [cm²]
Treatment area (facial adapter)	1.72 [cm²]
Max number of Flashes:	150,000 times
Non-continuous operation	1min on / 3min off

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Power Supply	100-240 VAC, 50/60Hz
Technology	IPL

10. Test Summary of non-clinical test

IPL Salon Hair Reduction System, Model: F60001 has been evaluated for the safety and performance by lab bench testing as follow:

� Electrical safety test according to IEC 60601-1 and IEC 60601-2-57 standards
� Electromagnetic compatibility test according to IEC 60601-1-2 standard
� Software verification and validation test according to the requirements of the FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices"
� Biocompatibility test according to ISO10993-5 and ISO10993-10.
� Usability study testing shown that the device can be used as intended.

11. Summary of the Technological Similarities and Differences

The technological characteristics, features, specifications, materials, and intended use of IPL Salon Hair Reduction System, Model: F60001 is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise different question of safety or effectiveness.

Elements ofComparison	Subject Device	Primary PredicateDevice	Reference PredicateDevice	Remark
Device Name andModel	IPL Salon HairReduction System,Model: F60001	PerfectSmooth (CB-014)	Lumena FH HairRemoval System	--
510(k) Number	Applying	K161428	K140631	--
Manufacturer	Medical Device Branchof Zhangzhou EasepalIndustrial Co.,Ltd.	Shen Zhen CosBeautyCo., Ltd.	Shaser, Inc.	--
Intended Use	The IPL Salon HairReduction System(Model: F60001) is anover the Counter deviceintended for the removalof unwanted body and/orfacial hair in adults. It isalso intended forpermanent reduction inunwanted hair.	The IPL Hair RemovalDevice Joy Version is anover-the-counter deviceintended for removal ofunwanted hair suchas but not limited tosmall areas such asunderarm and facial hairbelow the chin line andlarge areas	Lumena FH is an overthe Counter deviceintended to providephototherapeutic light tothe body. It is alsointended for removal ofunwanted hair by usinga selective photothermaltreatment. It is alsoindicated for the	SE
Elements ofComparison	Subject Device	Primary PredicateDevice	Reference PredicateDevice	Remark
	Permanent hairreduction is defined asthe long-term stablereduction in the numberof hairs re-growing whenmeasured at 6. 9. and12 months after thecompletion of atreatment regimen.	such as legs.	removal of unwantedbody and/or fhcial hairin adultswith Fitzpatrick skintypes I - IV. TheLumena PH is alsointended for permanentreduction in unwantedhair. Permanent hairreduction is defined asthe long-term stablereduction in the numberof hairs regrowing whenmeasured at 6,9 and 12months after thecompletion of atreatment regimen.
Source Energy	Supplied by externaladapter	an external power supply	AC Mains	SENote 1
'Use'Classification	OTC	OTC	OTC	SE
DeviceClassification	Class II	Class II	Class II	SE
Device Type	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	SE
Wavelength (nm)	475nm~1200nm	475nm~1200nm	400nm~1200nm	SENote 2
Max. Fluence(J/cm2)	Max 5.0 [Joules/cm²]	4.7[Joules/cm²]	Max 10 [Joules/cm²]	SENote 3
Spot Size (cm2)	1.72 cm² or 3.02 cm²	4.5[cm²]	2[cm²]	SENote 4
Pulse duration	11-12 ms	11-13milliseconds	--	SE
Energy medium	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp	SE
Pulsing Control	Finger switch	Finger switch	Finger switch	SE
Number of OutputChannels	One channel	One channel	One channel	SE
Output IntensityLevel	5 levels	--	5 levels	SE
Elements ofComparison	Subject Device	Primary PredicateDevice	Reference PredicateDevice	Remark
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	SE
60601 Compliancewith VoluntaryStandards	YesComply with IEC 60601-1 and IEC 60601-1-2,IEC60601-2-57	YesComply with IEC60601-1 and IEC 60601-1-2,IEC60601-2-57	YesComply with IEC 60601-1 and IEC 60601-1-2,IEC60601-2-57,	SE
Compliance* with21 CFR 898	No	No	No	SE
Weight	650g	--	1Kg	SENote 1
Dimensions	14369.543mm(HWD)	--	221678cm (HWD)	SENote 1
Standards
Biocompatibility	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements.	All user directly contactingmaterials are compliancewith ISO10993-5 andISO10993-10requirements.	All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements.	SE
Electrical Safety	Comply withIEC60601-1 andIEC60601-2-57	Comply withIEC 60601-1 andIEC 60601-2-57	Comply withIEC 60601-1 andIEC 60601-2-57	SE

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Comparison in Detail(s):

Note 1:

"Power Source(s)", "Weight", "Dimensions" is belong to basic characteristics. Although it is a little different from the predicate devices, it will not affect the main function and the intended use of the device. They all also comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue.

Note 2:

Although the Max. Fluence of subject device is a little larger than the one of the Primary Predicate device, but comparing to Reference Predicate device, the energy density of subject device is less than 10 Joules/cm². And they all comply with IEC 60601-1, IEC 60601-2-57 requirement. So the differences of function specification will not raise any safety or effectiveness issue.

Note 3:

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Although the wavelength of subject device is a little different from the predicate devices, but they all comply with IEC 60601-1, IEC 60601-2-57 requirement.

And the wavelength of subject device is in the range of predicted device "PerfectSmooth".

So the differences of function specification will not raise any safety or effectiveness issue.

Note 4:

The types of "Spot Size (cm2)" of subject device, and there is minor difference between the subject device and the predicate devices .And they all comply with IEC 60601-1, IEC60601-2-57 requirement.

So the differences of Spot size will not raise any safety or effectiveness issue.

Clinical testing:

No clinical testing was performed

Conclusion:

The subject device "IPL Salon Hair Reduction System, Model: F60001" is substantial Equivalence to all 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.