The Aimanfun Lumea Comfort (Model: A-2789, A-3588) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The Aimanfun Lumea Comfort 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 regrowing when measured at 6. 9. and 12 months after the completion of a treatment regimen.

Device Description

Aimanfun Lumea Comfort is a light-based device for long-term hair removal, designed for home environment used. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve long-term hair removal results at a fraction of the energy level used in other light-based hair removal equipment.

The device uses a Xenon Lamp to emit specified wavelength pulsed light to heat the root where the hair grows, and a skin proximity sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

The device is a home-use and hand-held device consists of main unit and adaptor, for the permanent reduction of hair growth based on Intense Pulsed Light (IPL).

AI/ML Overview

This document (K212907) is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the "Aimanfun Lumea Comfort" hair removal device. It primarily discusses the substantial equivalence of the new models (A-2789, A-3588) to a previously cleared predicate device (A-2788).

Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of clinical performance or algorithm performance.

Instead, it relies on the concept of substantial equivalence to a predicate device. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device, and therefore does not require new comprehensive clinical trials or extensive performance testing if the modifications are not deemed to raise new questions of safety or effectiveness.

The document states:

"As the modifications of subject device as above, results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device are suitable for use in the assessment of the subject device. So this submission leverages performance and electrical testing provided in previous submissions." (Page 5, Section 8: Performance Testing)
"Clinical performance is not deemed necessary." (Page 6, Section 10: Clinical performance)

Therefore, based on the provided text, I cannot extract the information required to answer your prompt because the submission itself did not include new clinical or algorithm performance studies for the modifications. The acceptance criteria and "device performance" in this context refer to the established safety and effectiveness of the predicate device and the demonstration that the new models do not introduce significant changes that would alter those characteristics.

To answer your prompt fully, a different type of document (e.g., a clinical study report or a detailed test report that would have been part of the original predicate device's 510(k) submission or a PMA application) would be needed.

However, I can extract what is stated regarding the basis of substantial equivalence:

Summary of what can be inferred from the document regarding the device's assessment:

Acceptance Criteria and Reported Device Performance: Not explicitly stated as new criteria or new performance data for this submission's devices. The acceptance is based on substantial equivalence to the predicate device, implying the predicate met its own performance criteria. The document states the new devices are "very similar in design principle, intended use, functions, material and the applicable standards" to the predicate.
Sample Size and Data Provenance:
- Test Set Sample Size: Not applicable/not provided for this submission in terms of new clinical/performance testing. The assessment leverages prior data from the predicate device.
- Data Provenance: Not explicitly stated for performance/clinical data, as it's not a new study. The manufacturer is Kam Yuen Plastic Products Ltd. based in China.
Experts for Ground Truth & Qualifications: Not applicable, as no new human-expert-validated test set was created for this submission.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is an IPL hair removal device, not an AI diagnostic/imaging device that typically undergoes MRMC studies.
Standalone Performance: Not applicable as a new study. The 'performance' is considered equivalent to the predicate device.
Type of Ground Truth: Not applicable for this submission. For the predicate device, the "ground truth" for "permanent hair reduction" would likely have been clinical measurements of hair regrowth at 6, 9, and 12 months post-treatment.
Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set in the typical sense. It's a physical device.
How Ground Truth for Training Set was Established: Not applicable.

In essence, the document confirms that the new models of the Aimanfun Lumea Comfort are substantially equivalent to the previously cleared A-2788 model, and therefore, new clinical performance data was not deemed necessary for this 510(k) submission. The FDA allows this pathway when modifications do not raise new questions of safety or effectiveness.

Summary

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

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.

December 2, 2021

Kam Yuen Plastic Products Ltd. % Jett Lee Regulation manager Guangdong Jianda Medical Technology Co Ltd 906 Room, Longxiang Garden, Tianhe District Guangzhou, Guangdong China

Re: K212907

Trade/Device Name: Aimanfun Lumea Comfort, A-2789/A-3588 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: ONF Dated: October 29, 2021 Received: November 3, 2021

Dear Jet Lee:

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.

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

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,

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K212907

Device Name Aimanfun Lumea Comfort , Model: A-2789, A-3588

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)
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."

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

510(k) Summary

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

1 Submitter Information

Sponsor: Kam Yuen Plastic Products Ltd. Establishment Registration Number: 10078856 Address: No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town, ZhongShan, Guangdong, China Phone: 86- 400- 962- 1668 Fax: 86-0760- 8841- 3080 Contact Person: Anna Dan E-mail: kamyuen@kyplastic.com

Application Correspondent: Jett Lee Company: Guangdong Jianda Medical Technology Co., Ltd E-mail: jianda-lee@foxmail.com Phone: 86-13512755282 Address: 906 Room, Longxiang Garden, Tianhe district, Guangzhou, China

Subject Device Information 2

Type of 510(k) submission: Special 510(k): Device Modification Common Name: Light based hair removal devices Trade Name: Aimanfun Lumea Comfort Model: A-2789, A-3588 Classification Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Review Panel: General & Plastic Surgery Product Code: ONF Regulation Number: 21 CFR 878.4810 Regulation Class: 2

3 Leqally marketed device (predicate device) Information

Common Name: Light based hair removal devices Trade Name: Aimanfun Lumea Comfort Model: A-2788 510K Number: K190820 Classification Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Review Panel: General & Plastic Surgery Product Code: ONF Regulation Number: 21 CFR 878.4810

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

Regulation Class: 2

4 Device Description

The device is a home-use and hand-held device consists of main unit and adaptor, for the permanent reduction of hair growth based on Intense Pulsed Light (IPL).

5 Intended Use

6 Complied Standards

Aimanfun Lumea Comfort (Model: A-2789, A-3588) complies with the following FDA recognized consensus standards:

മ IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2012 +A1:2012
区 IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
网 IEC 60601-1-11:2015 Medical Electrical Equipment -Part 1: 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
区 IEC 60601-2-57:2011 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 cos metic/aesthetic use
ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: ಷ

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

Tests For In Vitro Cytotoxicity

网 ISO 10993-10:2010, Biological Evaluation Of Medical Devices Part 10: Tests For Irritation And Skin Sensitization
Guidance for the Content of Premarket Submissions for Software Contained in 区 Medical Devices

7 Device modification description

All the modifications of subject device are shown in the following table as below, and no other changes were made to legally existing predicate device.

Designmodification	Before modification	After modification
Model name	A-2788	A-2789	A-3588
Appearance	Image: A-2788	Image: A-2789	Image: A-3588
Structure andButtons	Skin Contact WindowIntegrated UV filterEnergy Level IndicatorReady LampPower Adapter	Skin Contact WindowIntegrated UV filterLCD ScreenPower Adapter	Skin Contact WindowIntegrated UV filterLCD ScreenPower AdapterIndicator Light
	5-level ButtonFlash Key	ON/OFF ButtonFlash Key	ON/OFF ButtonICE ButtonFlash Key
Work mode	Single flash mode	Single flash modeSliding flash mode	Single flash modeSliding flash mode
Ice-sensingfunction	No	No	Yes
DimensionsWDH	82x138.9x47.3(mm)	82x138.9x47.5(mm)	74x135x233(mm)
Weight	200g	241g	360g

8 Performance Testing

As the modifications of subject device as above, results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device are suitable for use in the assessment of the subject device. So this submission leverages performance and electrical testing provided in previous submissions.

9 Biocompatibility

All the modified device materials which come in direct contact with the patient skin are biocompatible and identical to the materials used in the predicate device manufacturing. This

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

submission leverages biocompatibility test report provided in previous submissions.

10 Clinical performance

Clinical performance is not deemed necessary.

11 Comparison with predicate device

Compare with predicate device, the subject device is very similar in design principle, intended use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness.

Elements ofComparison	Subject Device		Predicate Device	Verdict
Manufacturer	Kam Yuen Plastic Products Ltd		Kam Yuen Plastic Products Ltd	--
Product Name	Aimanfun Lumea Comfort		Aimanfun Lumea Comfort	--
Model	A-2789	A-3588	A-2788	--
510(K) No.	TBD		K190820	--
Indications forUse	The Aimanfun Lumea Comfort (Model: A-2789,A-3588) is indicated for patient removal ofunwanted hair by using a selectivephotothermal treatment under the direction of aphysician, after training by a healthcareprofessional. The Aimanfun Lumea Comfort isalso intended for permanent reduction inunwanted hair. Permanent hair reduction isdefined as the long-term stable reduction in thenumber of hairs regrowing when measured at6, 9, and 12 months after the completion of atreatment regimen.		The Aimanfun Lumea Comfort(Model: A-2788) is indicated forpatient removal of unwanted hairby using a selective photothermaltreatment under the direction of aphysician, after training by ahealthcare professional. TheAimanfun Lumea Comfort is alsointended for permanent reductionin unwanted hair. Permanent hairreduction is defined as the long-term stable reduction in thenumber of hairs regrowing whenmeasured at 6, 9, and 12 monthsafter the completion of a treatmentregimen.	SE
IFU Type	Prescription use	Prescription use	Prescription use	SE
Classification	OHT/ONF	OHT/ONF	OHT/ONF	SE
Technology	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	SE
Device Design
Device Type	Hand-held	Hand-held	Hand-held	SE
Status display	LCD screen	LCD screen	LED indicators	SENote 1
Work mode	Single flash modeSliding flash mode	Single flash modeSliding flash mode	Single flash mode	SENote 2
Ice-sensingfunction	No	Yes	No	SENote 3
Power source	External power supply	External power supply	External power supply	SE
Elements ofComparison	Subject Device	Predicate Device	Verdict
Light source	Xenon Arc Flashlamp	Xenon Arc Flashlamp	SE
Wavelength	475~1200nm	475~1200nm	SE
Spot Size	3.0 cm2	3.0 cm2	SE
Max. Fluence	4.5 J/cm²	4.5 J/cm²	SE
Pulse duration	3 milliseconds	3 milliseconds	SE
Output energy	7-13.5 J	7-13.5 J	SE
Pulsing Control	Finger switch	Finger switch	SE
Delivery Device	Direct Illumination to Tissue	Direct Illumination to Tissue	SE
SoftwareControl	Yes	Yes	SE
FDA-Recognized Standards
	IEC 60601-1	IEC 60601-1
Electrical	IEC 60601-1-2	IEC 60601-1-2
safety, EMC,BiologicalEvaluation	IEC 60601-1-11	IEC 60601-1-11	SE
	IEC 60601-2-57	IEC 60601-2-57
	ISO 10993-5	ISO 10993-5
	ISO 10993-10	ISO 10993-10

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

Note 1

Although the subject device utilizes a LCD screen instead of indicator lamps to display device status, such as Device On/Off, Output Energy Level, Flash Ready/Recharging and Lamp lifetime, those do not result in a change in functionality and technical specification. So the difference does not affect the safety and effectiveness.

Note 2

Although the subject device provides extra sliding flash mode, which is only to trigger IPL flash continuously, instead of manually trigger under single flash mode. The difference does not result in a change of IPL technical specifications, so the difference does not affect the safety and effectiveness.

Note 3

Although the subject device (model: A-3588) provides an ice-sensing function, which utilizes a thermoelectric cooler under the skin contact window, the function is only to make patients comfortable with slightly cool sensation after IPL treatment, and have no therapeutic effect. The difference does not result in a change of IPL technical specifications, so the difference does not affect the safety and effectiveness.

Conclusion

The subject device has all features of the predicate device for intended use. Thus, the subject device is substantially equivalent to the predicate 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.