LED Phototherapy Device

K162098 · Li-Tek Electronic Technology Corporation · OLP · Jan 30, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K162098
• Device Name: LED Phototherapy Device
• Applicant: Li-Tek Electronic Technology Corporation
• Product Code: OLP · General, Plastic Surgery
• Decision Date: Jan 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

LED Phototherapy Device (Model PL-120) is a handheld, battery-powered light therapy system for OTC use. Device utilizes two interchangeable LED lamp heads: blue light (415nm) for mild-to-moderate inflammatory acne and red light (630nm) for periorbital wrinkles. User selects lamp head and treatment duration (1-4 minutes or continuous) via device controls. Device is held 2-3cm from skin surface; no direct skin contact occurs. Output consists of photon light energy at specified wavelengths and power densities. Device provides non-invasive treatment; intended to improve skin appearance and manage acne symptoms. Safety features include auto-off timers and compliance with photobiological safety standards.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance verified via electrical safety (IEC 60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), photobiological safety (IEC 62471), and software verification/validation.

Technological Characteristics

Handheld LED device; ABS plastic housing; 3.7V 1050mAh rechargeable Li-ion battery. Emits red (630nm±3nm) or blue (415nm±3nm) light. Power density: 80mW/cm² (red), 65mW/cm² (blue). Irradiation area: 30cm². Operates at 2-3cm distance from skin. Microprocessor-controlled with selectable auto-off timers. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, and IEC 62471.

Indications for Use

Indicated for treatment of periorbital wrinkles (red light) and mild to moderate inflammatory acne (blue light) in patients using the device over-the-counter.

Regulatory Classification

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.

Predicate Devices

• Acne Treatment device (K121435)
• Quasar Calypso (K111286)
• Nutra Light Red (K141308)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone]
- � Fax: [phone]
- Contact Person (including title): Barry Yuan (Quality Director) �
- E-mail:[e-mail] �

#### 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: [phone] �
- Email: [e-mail] �

#### 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 |
| Regulation<br>Number | 878.4810 | 878.4810 and<br>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.

| Component of<br>Device Requiring<br>Biocompatibility | Material of<br>Component | Body Contact<br>Category<br>(ISO 10993-1) | Contact Duration<br>(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 (L*W*H) | 187*65*51mm |
| 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<br>treatment skin surface | 2-3cm |
| Li battery | 3.7V, 1050mAh |
| Maximum charging time | 3 hours |
| work<br>environment | Temperature 5°C-40°C<br>relative humidity 10%-80%<br>atmospheric pressure 700hPa~1060hPa |
| Transportati<br>on and<br>storage<br>conditions | Temperature -10°C-40°C<br>relative humidity 5%-95%<br>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 of<br>Comparison | Subject Device | Predicate Device | | | Remark |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name<br>and Model | LED Phototherapy<br>Device. Model:PL-120 | Silkn Blue | Quasar Calypso | Nutra Light<br>Red | -- |
| 510(k) Number | Applying | K121435 | K111286 | K141308 | -- |
| Manufacturer | Li-Tek Electronics<br>Technologies | Home<br>Skinovations Ltd | PhotoActif, LLC | NutraLuxe MD,<br>LLC | -- |
| Product Code | OLP | OLP | OLP | OHS | -- |
| Regulation<br>Number | 878.4810 | 878.4810 | 878.4810 and<br>890.5500 | 878.4810 | -- |
| Intended Use | The red light is<br>intended for the<br>treatment of periorbital<br>wrinkles, and the blue<br>light is intended for the<br>treatment of the mild to<br>moderate inflammatory<br>acne. | The Silkn Blue is<br>indicated as an<br>over the counter<br>phototherapy<br>device for the<br>treatment of mild<br>to moderate acne. | The Quasar Calypso<br>C5O is intended to<br>emit energy in the red<br>and blue region of the<br>spectrum, specifically<br>indicated to treat mild<br>to moderate acne<br>vulgaris. | The Nutra Light<br>Red is a non-<br>invasive LED light<br>device is<br>intended/indicated<br>for over- the -<br>counter use for the<br>treatment of<br>periorbital<br>wrinkles, and<br>rhytides | SE |
| Basic Unit Characteristics | | | | | |
| Power<br>Source(s) | 3.7V 1050mAh Li<br>battery | battery | 12 volt wall mount<br>power | internal NI-MH<br>rechargeable<br>battery | SE<br>Note 1 |
| Software/Firm<br>ware/Micropro<br>cessor<br>Control? | Yes | Yes | Yes | No | SE<br>Note1 |

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

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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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