The IPL Hair Removal Device Joy Version 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. The device is used for adults with Fitzpatrick skin types I - IV.

Device Description

IPL Hair Removal Device Model: CB-027, a small over-the-counter, is a home-use device for the permanent reduction of hair growth based on 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. A personal Light-Based Hair Removal System. Emission 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 402g, and the size is 126 x 78 x 200mm (H x W x D).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

Here's a breakdown of the acceptance criteria and the study information for the IPL Hair Removal Device Joy Version, Model: CB-027, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than setting specific quantifiable acceptance criteria for clinical efficacy (e.g., specific percentage reduction in hair regrowth). Instead, the acceptance criteria are implicitly met by showing the device performs similarly or within acceptable ranges compared to its predicates and adheres to relevant safety standards.

Acceptance Criteria Category	Specific Criteria (Implicitly met by S.E. to predicates and standards compliance)	Reported Device Performance (from the document)
Intended Use	Identical or substantially similar to predicate devices for hair removal and permanent reduction in hair regrowth for Fitzpatrick skin types I-IV.	The IPL Hair Removal Device Joy Version is indicated for the removal of unwanted hair and permanent reduction in hair regrowth, defined as long-term, stable reduction at 6, 9, and 12 months post-treatment, for adults with Fitzpatrick skin types I-IV. This is stated to be "SE" (substantially equivalent) to predicate devices.
Technological Characteristics	Similar core technology (IPL), wavelength range, max fluence, spot size, pulse duration, energy medium, and pulsing control as predicate devices.	Technology: IPL Wavelength (nm): 510nm~~1200nm (Predicate I: 510nm~~1100nm, Predicate II: 475nm~1200nm) Max. Fluence (J/cm²): 5.1 J/cm² (Predicate I: 3-6 J/cm², Predicate II: 4.7 J/cm²) Spot Size (cm²): Body: 4.2 cm², Bikini and Face: 2 cm² (Predicate I: 3 cm², Predicate II: 4.5 cm²) Pulse duration: 9.20-11.20 milliseconds (Predicate I: 2 ms-10 ms, Predicate II: 11-13 milliseconds) Energy medium: Xenon Arc Flashlamp Pulsing Control: Finger switch Differences are noted to "not raise any safety or effectiveness issue" (Notes 2-5 in the document).
Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-2-57 standards.	Complies with IEC 60601-1 and IEC 60601-2-57 standards.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 standard.	Complies with IEC 60601-1-2 standard.
Software Verification & Validation	Compliance with FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices."	Software verification and validation test completed according to FDA guidance.
Biocompatibility	User-contacting materials comply with ISO10993-5 and ISO10993-10 requirements.	All user directly contacting materials (ABS for housing and plastic plate of lamp cartridge) are compliant with ISO10993-5 and ISO10993-10. These materials are identical to an already cleared predicate device (K161428).
Usability (Human Factors)	Lay users can self-select, apply treatment safely/correctly, and understand indications/contraindications/warnings/precautions from labeling.	Usability testing (OTC Study) was completed in 78 subjects. The test demonstrated that the device and its labeling meet the requirements for lay user comprehension and safe application.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- For the Usability Study: 78 subjects.
- For the Technical/Safety Bench Testing (Electrical safety, EMC, Software V&V, Biocompatibility): No specific sample size of "test subjects" is mentioned, as these are lab-based evaluations of the device itself (e.g., material samples for biocompatibility, the device unit for electrical tests).
Data Provenance: The document does not explicitly state the country of origin for the usability study participants. Given the company's location (Shenzhen, China) and the correspondent's location (Guangzhou, China), it is highly probable the usability study was conducted in China. The study appears to be prospective for the usability testing as it involved new subjects interacting with the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Usability Study: The document does not specify the number or qualifications of "experts" used to establish ground truth. Usability studies primarily focus on lay-user performance and comprehension rather than expert-established clinical ground truth. The "ground truth" here is whether the average user can successfully and safely use the device and understand its instructions, as evaluated by direct observation and feedback from the 78 subjects.
For the technical tests (electrical safety, EMC, software V&V, biocompatibility), compliance is measured against established international standards and FDA guidance, meaning the "ground truth" is adherence to these predefined criteria, verified by qualified testing laboratories.

4. Adjudication Method for the Test Set

Usability Study: The document does not describe a formal adjudication method (like 2+1 or 3+1). Usability studies typically involve observing participants, analyzing their actions, and reviewing their responses to questions to determine if performance objectives are met. Discrepancies might be resolved through internal review by the study team, but no specific external adjudication process is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This device is an over-the-counter hair removal device. Clinical efficacy studies for such devices typically focus on hair reduction percentages rather than human reader interpretation of images. Human readers are not involved in the direct output or application of this device.

6. Standalone Performance Study

Yes, a standalone study was done in the form of the usability study and the bench testing.
- The usability study (78 subjects) evaluates the device's performance when used by lay users, which is the "algorithm only" equivalent for a consumer-facing device where the "algorithm" is the user interface, instructions, and intended operation.
- The bench testing (electrical safety, EMC, software V&V, biocompatibility) evaluates the device's physical and technical characteristics in a standalone manner against predefined standards.

7. Type of Ground Truth Used

Usability Study: The ground truth was based on lay user performance observation and comprehension metrics against predefined usability goals (e.g., successful self-selection, correct application, understanding labeling).
Technical Bench Testing: The ground truth was based on compliance with established international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, ISO10993-5, ISO10993-10) and FDA guidance ("Guidance for PreMarket Submissions and for Software Contained in Medical Devices").

8. Sample Size for the Training Set

Not Applicable. This document describes a 510(k) submission for a physical medical device (an IPL hair removal device), not an AI/ML algorithm that requires a "training set." The software mentioned refers to internal device control, not a learning algorithm that would be "trained" on data.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As explained above, there is no mention or implication of a "training set" for an AI/ML algorithm in this submission.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 7, 2018

Shen Zhen CosBeauty Co., Ltd Ms. Iris Fung Regulation manager SGS-CSTC Standards Technical Services Co., Ltd. 198 KEZHU Road, SCIENTECH Park Guangzhou Guangzhou. Cn

Re: K173813

Trade/Device Name: IPL Hair Removal Device Joy Version 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: August 28, 2018 Received: August 31, 2018

Dear Ms. 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/cfdocs/cfpmr/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/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 (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 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 Stevensor

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) K173813

Device Name

IPL Hair Removal Device Joy Version, Model: CB-027

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 7, 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

Sponsor

� Company Name: Shenzhen CosBeauty Technology Co., Ltd.
Address: UnitA-3F, Qiao De Industrial Park, Tian Liao, Guang Ming District, Shenzhen, � China
Phone: +86 1831 685 8036 �
� Fax: +86 755 8629 0505
� Contact Person (including title): Nicole Hu
E-mail: lizan@cos-beauty.com �

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 Hair Removal Device Joy Version, Model: CB-027
Light Based Over-The-Counter Hair Removal � Common Name:
Laser surgical instrument for use in general and plastic � Classification name: surgery and in dermatology
General & Plastic Surgery � Review Panel:
ОНТ Product Code: �
2 � Regulation Class:
878.4810 � Regulation Number:

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3. Predicate Device Information

Sponsor	Cyden Limited	Shenzhen CosBeautyTechnology Co., Ltd.
Device Name	IpulseSmoothskin GoldHair RemovalDevice	PerfectSmooth
510(k) Number	K160968	K161428
Product Code	ONF	OHT
RegulationNumber	878.4810	878.4810
Regulation Class	2	2

2. Device Description

5. Intended Use / Indications for Use

6. Design

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 triggerred a pulse emitting. Body lamp cartridge can be used for body hair below the neck. It can cover an area of 4.2cm2, and it is specially designed for large areas on legs, arms, back and abdomen. It can remove hair in a large scope rapidly. Do not use Body lamp cartridge on face. A filter has been installed in the face lamp cartridge. It can cover an area of 2cm2, and it can be used to remove hair on upper lip, chin and sideburns. Do not use this lamp cartridge on the areas around eyes or near eyelid. The product can flash for 300,000 times, and it shall not be used when the flash counter is displaying "000000".

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7. Materials

There are two patient- directly contracting components in the subject device as the following list.

Component ofDevice RequiringBiocompatibility	Material ofComponent	Body ContactCategory(ISO 10993-1)	Contact Duration(ISO 10993-1)
Housing	ABS	Surface-contactingdevice: skin	Maximum 30minutes(< 24hours)
Plastic plate of lampcartridge	ABS	Surface-contactingdevice: skin	Maximum 30minutes(< 24hours)

Both materials is identical to the material of the device PerfectSmooth, which is cleared by FDA with K161428, produced by us. So these parts' biocompatibility is safe.

8. Physical characteristics

Basic Unit Characteristics
Compliance* with 21 CFR 898	No
Main Unit Weight	402g
Main Unit Dimension	12678200mm
Housing Materials of main unit	PC2805
Indicator	Indicates power information, intensity level information.
Environment for operation	Temperature: 5°C~35°C
Storage and Transport Conditions	Temperature: -10°C~55°C
Compliance with Voluntary Standards	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/Microprocessor Control?	Yes
Specification
Output Intensity Level	5
Output energy with body lamp cartridge	Level 1: 11.77J
	Level 2: 14.12J
	Level 3: 17.12J
	Level 4: 19.95J
	Level 5: 22,21J
Output energy with facial lamp cartridge	Level 1: 3.65J
	Level 2: 4.59J
	Level 3: 5.33J
	Level 4: 6.16J
	Level 5: 7.04J
Output energy with bikini lamp cartridge	Level 1: 3.84J
	Level 2: 4.92J

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	Level 3: 5.43J
	Level 4: 6.23J
	Level 5: 7.22J
Emitted Light Spectrum	510nm~1200nm Max
Max Energy density:	5.1 J/cm²,
Pulse duration	9.20~11.20milliseconds
Treatment Area (regular window)	Body: 4.2 [cm²], Bikini area and Face: 2 [cm²]
Flashes:	300,000 times
Power Supply	100-240 VAC, 50/60Hz
Technology	IPL

10. Test Summary

IPL Hair Removal Device Joy Version, Model: CB-027 has been evaluated the safety and performance by lab bench testing as following:

� 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"
� Usability study:

Usability testing (OTC Study) was completed in 78 subjects to evaluate device human factors and label comprehension.

These usability study tests demonstrate that the device and its labeling can meet with the requirement:

the lay user can self-select themselves as being appropriate users of this device by the external box labeling, 2) the lay user can apply the treatment safely and correctly according to the instructions for use, and 3) the lay user can understand all indications, contraindications, warnings and precautions, and be able to identify whether they are within any contraindicated group; and be able to understand the user manual.

11. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of IPL Hair Removal Device Joy Version, model: CB-027 is substantially equivalent to the predicate devices quoted above.

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

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Elements ofComparison	Subject Device	Predicate Device I	Predicate Device II	Remark
Device Name andModel	IPL Hair Removal DeviceJoy Version, Model: CB-027	iPulse SmoothSkinGold	PerfectSmooth (CB-014)	--
510(k) Number	Applying	K160968	K161428	--
Manufacturer	Shenzhen CosBeautyTechnology Co., Ltd.	CyDen Ltd	Shenzhen CosBeautyTechnology Co., Ltd.	--
Intended Use	The IPL Hair RemovalDevice Joy Version isindicated for the removalof unwanted hair. Thedevice is also indicated forthe permanent reductionin hair regrowth, definedas the long-term, stablereduction in the number ofhairs regrowing whenmeasured at 6, 9 and 12months after thecompletion of a treatmentregime. The device isused for adults withFitzpatrick skin types I –IV.	The iPulse SmoothSkinGold Hair RemovalSystem is indicated forthe removal ofunwanted hair. TheiPulse SmoothSkin Goldis also indicated for thepermanent reduction inhair regrowth, definedas the long-term,stable reduction in thenumber of hairsregrowing whenmeasured at 6, 9 and 12months after thecompletion of atreatment regime.	The IPL Hair RemovalDevice Joy Version isan over-the-counterdevice intended forremoval of unwantedhair suchas but not limited tosmall areas such asunderarm and facial hairbelow the chin line andlarge areassuch as legs.	SE
Source Energy	Supplied by externaladapter	AC Mains	an external powersupply	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)	510nm~1200nm	510nm~1100nm	475nm~1200nm	SENote 2
Max. Fluence(J/cm2)	5.1 [Joules/cm²]	3-6 [Joules/cm²]	4.7[Joules/cm²]	SENote 3
Spot Size (cm2)	Body: 4.2 [cm²], Bikini andFace: 2 [cm²]	3[cm²]	4.5[cm²]	SENote 4
Pulse duration	9.20-11.20milliseconds	2 ms- 10 ms	11-13milliseconds	SE
Elements ofComparison	Subject Device	Predicate Device I	Predicate Device II	Remark
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 energyAND Energyspectrum	bodylampcartridge	Level 1: 11.77J@510nm~~1200nmLevel 2: 14.12J@510nm~~1200nmLevel 3: 17.12J@510nm~~1200nmLevel 4: 19.95J@510nm~~1200nmLevel 5: 22,21J@510nm~1200nm	9- 18J @510nm~1100nm	Level 1: 11.5J @475nm~~1200nmLevel 2: 15.0J @475nm~~1200nmLevel 3: 17.0J@475nm~~1200nmLevel 4: 20.0J@475nm~~1200nmLevel 5: 22,0J@475nm~1200nm	SENote 5
	faciallampcartridge	Level 1: 3.65J@512nm~~1197nmLevel 2: 4.59J@512nm~~1197nmLevel 3: 5.33J@512nm~~1197nmLevel 4: 6.16J@512nm~~1197nmLevel 5: 7.04J@512nm~1197nm
	bikinilampcartridge	Level 1: 3.84J@511nm~~1200nmLevel 2: 4.92J@511nm~~1200nmLevel 3: 5.43J@511nm~~1200nmLevel 4: 6.23J@511nm~~1200nmLevel 5: 7.22J @511nm~1200nm
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	SE
60601Compliancewith VoluntaryStandards	YesComply with IEC 60601-1and IEC 60601-1-2,IEC60601-2-57	YesComply with IEC 60601-1 and IEC 60601-1-2,IEC60601-2-57,	YesComply with IEC60601-1 and IEC60601-1-2,IEC60601-2-57	SE
Elements ofComparison	Subject Device	Predicate Device I	Predicate Device II	Remark
Compliance* with21 CFR 898	No	No	No	SE
Weight	402g	1Kg	--	SENote 1
Dimensions	12678200mm	1323565mm (HWD)	--	SENote 1
Standards
Biocompatibility	All user directly contactingmaterials are compliancewith ISO10993-5 andISO10993-10requirements.	All user directlycontacting materials arecompliance withISO10993-5 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 predicate device II, but comparing to Predicate device II, 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:

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 the one of predicted devices "PerfectSmooth"

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

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Note 4:

There are three types of "Spot Size (cm2)" of subject device, and there is minor difference between the subject device and the predicate device I, but in predicate device II, there is similar spot size to the size of bikini area /face lamp cartridge in subject device. 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.

Note 5:

For IPL light, the energy spectrum is Continuous wavelength range. So even there is minor value difference on the energy spectrum between subject device and predicate devices, but the total energy output density (Max. Fluence value) is similar; and they comply with IEC60601-2-57 Requirement. So the differences of energy spectrum will not raise any safety or effectiveness issue.

And for facial lamp cartridge and bikini lamp cartridge, even the max output energy is lower than the data of predicate devices of K161428/K160968 due to the difference of spot size, but the total energy output density (Max. Fluence value) is similar; and the maximum output energy density of subject device for facial lamp cartridge is about 3.52 J/cm2; and 3.61 J/cm2 for bikini lamp cartridge. Comparing with the predicate device of K 160968, the value range of energy density of predicate device of K160968 is 3-6 J/cm2, which can cover the maximum output energy density of subject device for facial lamp cartridge and bikini lamp cartridge. The phototherapy effectiveness is crucially related to the output energy density and wavelength parameters for IPL, and the output energy of one pulse is minor different to predicate devices because of its spot window size. The spot size of device only affect the treatment target skin area per each pulse flashing, it do not raise any safety or effectiveness issue.

So the differences of output energy for facial lamp cartridge and bikini lamp cartridge will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject device " IPL Hair Removal Device Joy Version, Model: CB-027" 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.