The red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

Device Description

The LED Phototherapy Device (Model: PL-120) directly applies photon light onto skin surface by making using of specific photon spectrum. Each device is equipped with two LED lamp holder, one is emitting blue light which wavelength at 415nm±3nm. The other lamp emits red light which wavelength at 630nm±3nm. The red light is intended for the treatment of periorbital wrinkles. The blue light is intended for the treatment of the mild to moderate inflammatory acne. The user can change the treatment lamp according to their own needs. It employed a 3.7 V Li-ion battery to provide power, and the internal battery is rechargeable. And the device has five options for setting the auto-off time, as below table listed:

AI/ML Overview

The provided document is a 510(k) summary for a medical device (LED Phototherapy Device) seeking substantial equivalence to predicate devices. It describes the device, its intended use, and test summaries for safety and performance. However, this document does not contain information about a clinical study involving human patients, multi-reader multi-case (MRMC) studies, or the use of AI.

The "Test Summary" section explicitly states that the device's safety and performance were evaluated by lab bench testing according to various IEC (International Electrotechnical Commission) standards for electrical safety, electromagnetic compatibility, and photobiological safety, as well as software verification and validation. There is no mention of clinical trials, human data, expert ground truth, or any form of AI performance evaluation.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria, device performance from a clinical study, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC study results because this information is not present in the provided text.

The document primarily focuses on demonstrating equivalence through technical specifications and adherence to safety and performance standards for a light therapy device, not through clinical efficacy trials or AI performance evaluation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 30, 2017

Li-Tek Electronic Technology Corporation % Jet Li Regulation Manager Guangzhou Leta Testing Technology Co.,Ltd 6F, No.1 Tian Tairoad Science City, LuoGang District Guang Zhou City, China

Re: K162098

Trade/Device Name: LED Phototherapy Device 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: OLP and OHS Dated: December 31, 2016 Received: January 10, 2017

Dear Jet Li:

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. 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 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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Jennifer R. Stevenson -S

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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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.

510k preparation date: 2017-01-25

1. Submitter's Information

Sponsor:

� Company Name: Li-Tek Electronics Technologies
� Address: No.8~13,the industrial park of Jinshagang, Shixia village, Dalang town,Dongguan city, Guangdong, China
� Phone: 0769-83117755
� Fax: 0769-83117759
Contact Person (including title): Barry Yuan (Quality Director) �
E-mail:quality5@li-tek.com �

Application Correspondent:

� Guangzhou LETA Testing Technology Co., Ltd.
� Address: 6F, No.1 TianTairoad, Science City, LuoGang District, GuangZhou City, China
� Contact Person: Mr. Jet Li
� Tile: Requlation Manager
Tel: +86-20-22325619 �
Email: med-jl@foxmail.com �

2. Subject Device Information

Type of 510(k) submission: Traditional

Common Name: Laser surgical instrument for use in general and plastic surgery and in dermatology.

Light Therapy system

Trade Name: LED Phototherapy Device

Classification Name: Light Based over the Counter Wrinkle Reduction, Over-the-counter

powered light based for acne

Review Panel: General&Plastic Surgery

Product Code: OLP, OHS

Regulation Number: 878.4810

Regulation Class: 2

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3. Predicate Device Information

Sponsor	Home Skinovations Ltd.	Silver Bay, LLC	NutraLuxe MD, LLC
Device Name	Acne Treatment device	Quasar Calypso	Nutra Light Red
510(k) Number	K121435	K111286	K141308
Product Code	OLP	OLP	OHS
RegulationNumber	878.4810	878.4810 and890.5500	878.4810
Regulation Class	2	2	2

4. Device Description

Mode Selection	Default Duration
1	Auto Off after running for 1 minute
2	Auto Off after running for 2 minute
3	Auto Off after running for 3 minute
4	Auto Off after running for 4 minute
L	Continuous working mode

5. Intended Use / Indications for Use

The red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

6. Materials

There are no patient directly components in the subject device as the following list.

Component ofDevice RequiringBiocompatibility	Material ofComponent	Body ContactCategory(ISO 10993-1)	Contact Duration(ISO 10993-1)
-	-	-	-

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The holding part is made of ABS plastic, which is widely used in various medical devices, and its biological compatibility has been proved to be acceptable in many marketed device. So biological compatility test was waived here for this material. The users should place the device 2-3cm away from face before use it. So the LED Phototherapy device is not used in skin contact.

7. Physical characteristics

Main Unit Weight	150g
dimensions (LWH)	1876551mm
Power Source	DC 5V, 1A
Maximum power	1.5W
light source	LED
Maximum emission wavelength	The red light: 630nm±3nm
	The blue light: 415nm±3nm
Power density	The red light: 80mW/cm2±10%
	The blue light: 65mW/cm2±10%
Irradiation area	30cm2±5%
The distance between the lamp totreatment skin surface	2-3cm
Li battery	3.7V, 1050mAh
Maximum charging time	3 hours
workenvironment	Temperature 5°C-40°Crelative humidity 10%-80%atmospheric pressure 700hPa~1060hPa
Transportation andstorageconditions	Temperature -10°C-40°Crelative humidity 5%-95%atmospheric pressure 600hPa~1060hPa

8. Test Summary

The LED Phototherapy Device has been evaluated the safety and performance by lab bench testing as following:

� Electrical safety and essential performance test according to IEC 60601-1; IEC 60601-2-57 IEC60601-1-11 standards
Electromagnetic compatibility test according to IEC 60601-1-2 standard �
Photobiological safety test according to IEC62471 �

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� Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Device"

9. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of the LED Phototherapy Device is substantially equivalent to the predicate device quoted above. The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device			Remark
Device Nameand Model	LED PhototherapyDevice. Model:PL-120	Silkn Blue	Quasar Calypso	Nutra LightRed	--
510(k) Number	Applying	K121435	K111286	K141308	--
Manufacturer	Li-Tek ElectronicsTechnologies	HomeSkinovations Ltd	PhotoActif, LLC	NutraLuxe MD,LLC	--
Product Code	OLP	OLP	OLP	OHS	--
RegulationNumber	878.4810	878.4810	878.4810 and890.5500	878.4810	--
Intended Use	The red light isintended for thetreatment of periorbitalwrinkles, and the bluelight is intended for thetreatment of the mild tomoderate inflammatoryacne.	The Silkn Blue isindicated as anover the counterphototherapydevice for thetreatment of mildto moderate acne.	The Quasar CalypsoC5O is intended toemit energy in the redand blue region of thespectrum, specificallyindicated to treat mildto moderate acnevulgaris.	The Nutra LightRed is a non-invasive LED lightdevice isintended/indicatedfor over- the -counter use for thetreatment ofperiorbitalwrinkles, andrhytides	SE
Basic Unit Characteristics
PowerSource(s)	3.7V 1050mAh Libattery	battery	12 volt wall mountpower	internal NI-MHrechargeablebattery	SENote 1
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	No	SENote1

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Elements ofComparison	Subject Device	Predicate Device			Remark
Power(mW/cm²)	Red light 80±10%Bule light 65±10%	50	65	80	SENote 1
treatmentduration	3 minutes per targetarea; 2 treatments perweek for 6 weeks	--;	3 minutes daily,minimum 5 days perweek	3min	SE
Compliancewith 21 CFR898	Yes	Yes	Yes	Yes	SE
HousingMaterials andConstruction	ABS plastic	Stainless steels17-4H,Rigid ABS	polycarbonate	medical gradebiocompatibilityplastics viainjection molding	SE
wavelength	blue light:415nm±3nmred light: 630nm±3nm	415±15nm	Blue light 405-420nm,red light628±10nm	The outputwavelength of Redis 650 +/- 5 at 80mW/cm2	SENote 2
Standards
Biocompatibility	ABS plastic in handhold part can beconsidered safety	All user directlycontactingmaterials arecompliance withISO10993-5 andISO10993-10requirements.	All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements.	All user directlycontactingmaterials arecompliance withISO10993-5 andISO10993-10requirements.	SE
ElectricalSafety	Comply with IEC60601-1	Comply with IEC60601-1	Comply with IEC / EN6060 1-1	Comply with IEC60601-1	SE
EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Comply with IEC60601-1-2	SE

Comparison in Detail(s):

Note 1:

"Power Source(s)""Power (mW/cm)"is belonging to basic characteristics. Although they are a little different from the predicate device, it will not affect the main function and the intended use of the device. They all also comply with IEC 60601-1, IEC 60601-1-2, IEC62471, for safety requirement, and comply with IEC60601-2-57 for essential requirements. So the differences will not raise any safety or effectiveness issue.

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Note 2: "wavelength" of subject device is a little different from the predicate device, they all comply with IEC62471, IEC60601-2-57requirement, so the differences of function specification will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject device LED Phototherapy Device is substantial equivalence to all predicate devices.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162098

Device Name LED Phototherapy Device

Indications for Use (Describe)

The red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

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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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.