Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties of light therapy and electrical/software safety, with no mention of AI or ML algorithms for analysis, treatment planning, or other functions.

Therapeutic

Yes
The device is intended for the treatment of periorbital wrinkles and mild to moderate inflammatory acne, which are therapeutic indications.

Diagnostic

No
The device is described as an LED Phototherapy Device intended for the treatment of periorbital wrinkles and mild to moderate inflammatory acne, which are therapeutic uses, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as LED lamp holders, a battery, and mentions electrical safety and electromagnetic compatibility testing, indicating it is a physical device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: This device directly applies light to the skin surface for therapeutic purposes (treating wrinkles and acne). It does not analyze any biological samples.

The description clearly indicates a therapeutic device that interacts directly with the patient's body, not a diagnostic device that analyzes samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

OLP, OHS

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:

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin surface, periorbital, face

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K121435, K111286, K141308

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

1

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

2

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

3

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
Regulation
Number	878.4810	878.4810 and
890.5500	878.4810
Regulation Class	2	2	2

4. 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:

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.

------------------------------------------------------	--------------------------	-------------------------------------------	-----------------------------------

4

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 to
treatment skin surface	2-3cm
Li battery	3.7V, 1050mAh
Maximum charging time	3 hours
work
environment	Temperature 5°C-40°C
relative humidity 10%-80%
atmospheric pressure 700hPa~1060hPa
Transportati
on and
storage
conditions	Temperature -10°C-40°C
relative 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 �

5

� 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 of

Comparison	Subject Device	Predicate Device			Remark
Device Name
and Model	LED Phototherapy
Device. Model:PL-120	Silkn Blue	Quasar Calypso	Nutra Light
Red	--
510(k) Number	Applying	K121435	K111286	K141308	--
Manufacturer	Li-Tek Electronics
Technologies	Home
Skinovations Ltd	PhotoActif, LLC	NutraLuxe MD,
LLC	--
Product Code	OLP	OLP	OLP	OHS	--
Regulation
Number	878.4810	878.4810	878.4810 and
890.5500	878.4810	--
Intended 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.	The Silkn Blue is
indicated as an
over the counter
phototherapy
device for the
treatment of mild
to moderate acne.	The Quasar Calypso
C5O is intended to
emit energy in the red
and blue region of the
spectrum, specifically
indicated to treat mild
to moderate acne
vulgaris.	The Nutra Light
Red is a non-
invasive LED light
device is
intended/indicated
for over- the -
counter use for the
treatment of
periorbital
wrinkles, and
rhytides	SE
Basic Unit Characteristics
Power
Source(s)	3.7V 1050mAh Li
battery	battery	12 volt wall mount
power	internal NI-MH
rechargeable
battery	SE
Note 1
Software/Firm
ware/Micropro
cessor
Control?	Yes	Yes	Yes	No	SE
Note1

6

| Elements of
Comparison | Subject Device | Predicate Device | | | Rema
rk |
|------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------|
| Power
(mW/cm²) | Red light 80±10%
Bule light 65±10% | 50 | 65 | 80 | SE
Note 1 |
| treatment
duration | 3 minutes per target
area; 2 treatments per
week for 6 weeks | --; | 3 minutes daily,
minimum 5 days per
week | 3min | SE |
| Compliance
with 21 CFR
898 | Yes | Yes | Yes | Yes | SE |
| Housing
Materials and
Construction | ABS plastic | Stainless steels
17-4H,
Rigid ABS | polycarbonate | medical grade
biocompatibility
plastics via
injection molding | SE |
| wavelength | blue light:
415nm±3nm
red light: 630nm±3nm | 415±15nm | Blue light 405-
420nm,red light
628±10nm | The output
wavelength of Red
is 650 +/- 5 at 80
mW/cm2 | SE
Note 2 |
| Standards | | | | | |
| Biocompatibilit
y | ABS plastic in hand
hold part can be
considered safety | All user directly
contacting
materials are
compliance with
ISO10993-5 and
ISO10993-10
requirements. | All user directly
contacting materials
are compliance with
ISO10993-5 and
ISO10993-10
requirements. | All user directly
contacting
materials are
compliance with
ISO10993-5 and
ISO10993-10
requirements. | SE |
| Electrical
Safety | Comply with IEC
60601-1 | Comply with IEC
60601-1 | Comply with IEC / EN
6060 1-1 | Comply with IEC
60601-1 | SE |
| EMC | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | 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.

7

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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