Photodynamic Therapy Device

K170187 · Uvbiotek, LLC · GEX · Jul 28, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170187
• Device Name: Photodynamic Therapy Device
• Applicant: Uvbiotek, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K170187 · Jul 28, 2017	Photodynamic Therapy Device	Uvbiotek, LLC	Human volunteer thermal performance testing	Thermal performance testing was conducted on human volunteers to verify that the device maintains skin temperature below 41 degrees Celsius during operation.	Thermal safety; Human volunteer testing

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Thermal performance test; Human volunteer testing; Follow-up/Duration: 20 minutes	Human volunteers	Not applicable for this study	Skin temperature maintenance (below 41 degrees C)

Indications for Use

The Photodynamic Therapy Device combination of Red (633nm=10mm) and Blue (417nm=10mm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

Device Story

The Photodynamic Therapy Device (KN-7000A) is a portable LED-based phototherapy system used in clinical settings to treat mild to moderate acne vulgaris. The device consists of a main frame, an irradiator, and a lifting stand. It emits red (633nm) and blue (417nm) light to the patient's skin. Operators (clinicians) set treatment parameters via a display screen interface. Patients must remove cosmetics, wash their face, and wear protective eyewear during the procedure. The irradiator is positioned 6cm from the treatment area. Treatment protocols involve alternating red and blue light irradiation for specified durations (13-30 minutes depending on the head type), twice weekly for 8 sessions. The device uses microprocessor control to manage light output. By delivering specific light energy, the device aims to reduce the appearance of acne, providing a non-invasive therapeutic option for dermatological management.

Clinical Evidence

Bench testing only. Compliance with AAMI/ANSI ES60601-1, IEC60601-1-2, and IEC60601-2-57 standards. Thermal performance testing on human volunteers confirmed skin temperature remains below 41°C after 20 minutes of use. Software verification performed per FDA guidance.

Technological Characteristics

Portable LED-based light therapy device. Emits red (633±10nm) and blue (417±10nm) light. Microprocessor-controlled. Operates at 100-240V, 50/60Hz. Effective irradiance area 800cm². Non-sterile. Standards: IEC60601-1, IEC60601-1-2, IEC60601-2-57.

Indications for Use

Indicated for patients with mild to moderate acne vulgaris.

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

• Aklarus Phototherapy System (K083183)

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 the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing right, with a wing-like shape extending from the first profile.

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

July 28, 2017

UVBIOTEK, LLC Zhou Jinghua Guangzhou Junyi Information Technology Co, Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, Guangdong, China 511660

Re: K170187

Trade/Device Name: Photodynamic Therapy 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: GEX Dated: July 3, 2017 Received: July 3, 2017

Dear Zhou Jinghua:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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), 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours, Jennifer R. Stevenson -S3

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) K170187

Device Name Photodynamic Therapy Device

Indications for Use (Describe)

The Photodynamic Therapy Device combination of Red (633nm=10mm) and Blue (417nm=10mm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

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)

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## Section 5 - 510(k) Summary

Date of Summary Preparation: July 14/2017

#### 1. Submitter's Identifications

Submitter's Name: UVBIOTEK, LLC Address: 3 Depot Street, Hudson Falls, NY 12839, United States Contact Person: Dave Oberhelman Contact Title: Plant Manager Contact E-mail Address: [e-mail] Telephone: [phone] Fax: [phone]

#### 2. Correspondent's Identifications

Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 215, Huaming Building, Chebei Road, Guangzhou, P.R. China ZIP Code: 511660 Contact Person: Zhou Jinghua Contact Title: Regulation Control Manager Contact E-mail Address: kernel [e-mail] Telephone: [phone] Fax: [phone]

#### 3. Name of the Device

Device Classification Name: Powered Laser Surgical Instrument Product Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Trade Name: Photodynamic Therapy Device Model: KN-7000A Classification Panel: General & Plastic Surgery Product Code: GEX Device Classification: Class II

#### 4. The Predicate Devices

K083183 Aklarus Phototherapy System

#### 5. Device Description

The Photodynamic Therapy Device KN-7000A is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. The device produces light in the red light region of the light spectrum (633±10mm) and/or in the

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blue light region of the light spectrum (417±10nm), intended to help reduce the appearance of mild to moderate acne. There are three irradiators available, Blue LED, Red LED and Blue/Red LED.

This device is mainly made up of the main frame, the irradiator, and the lifting stand.

After installing the KN-7000A Photodynamic Therapy Device, the phototherapy patient should be instructed to remove cosmetics, wash their face with water and wipe it dry before therapy. The special protective eyewear should be used to cover both eyes to prevent possible injury by the irradiator. Set treatment parameters on the main interface of the screen, operate the irradiator and make sure that the correct operating distance (6cm±1cm) from the patient's treatment area.

When using pure red, pure blue treatment head alternate irradiation, pure red LEDs irradiates 15 minutes per treatment, pure blue LEDs irradiates 13 minutes per treatment, twice weekly, 8 times per course of treatment; When using red and blue combination treatment head alternate irradiation, red LEDs irradiates 30 minutes per treatment, blue LEDs irradiates 22 minutes per treatment, twice weekly, 8 times per course of treatment.

#### 6. Intended Use of Device

7. Summary of Substantial Equivalence

The Photodynamic Therapy Device combination of Red (633nm±10nm) and Blue (417nm±10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

| | Proposed Device | Predicate device | Comparison |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k Number | K170187 | K083183 | ----- |
| Product Code | GEX | ILY GEX | Same |
| Proprietary<br>Name | Photodynamic Therapy<br>Device | Aklarus Phototherapy<br>System | ----- |
| Model | KN-7000A | Aklarus Phototherapy<br>System | ----- |
| Manufacturer | Xuzhou Kernel Medical<br>Equipment Co., Ltd. | Hill Laboratories | ----- |
| Indications for<br>use | The Photodynamic Therapy<br>Device combination of Red<br>(633nm $\pm$ 10nm) and Blue<br>(417nm $\pm$ 10nm) is intended<br>to emit energy in the red,<br>blue regions of the<br>spectrum to treat<br>dermatological conditions,<br>specifically indicated to<br>treat mild to moderate acne<br>vulgaris. | The Aklarus Blue (420nm<br>$\pm$ 10nm), is generally<br>indicated to treat<br>dermatological conditions<br>and specifically indicated<br>to treat moderate<br>inflammatory acne<br>vulgaris.<br>The Aklarus combination<br>of Red (628nm $\pm$ 10nm)<br>and Blue (420nm $\pm$ 10nm) | Same. The<br>indications for<br>use of<br>KN-7000A are<br>contained in<br>those of the<br>predicate<br>device. |
| | | | |
| | | is intended to emit energy<br>in the red, blue regions of | |
| | | the spectrum to to to treat | |
| | | dermatological conditions, | |
| | | | |
| | | specifically indicated to | |
| | | treat mild to moderate acne | |
| | | vulgaris. | |
| | | The Aklarus Anti-Aging | |
| | | Red (628nm +/-10nm) and | |
| | | Anti-Aging | |
| | | (880nm+/-10nm) | |
| | | Combination is intended to | |
| | | emit energy in the red and | |
| | | infra-red region of the | |
| | | spectrum for for use in | |
| | | dermatology | |
| | | treatment of of periorbital | |
| | | wrinkles. | |
| | | The | |
| | | (880nm | |
| | | intended to emit energy in | |
| | | the IR spectrum to provide | |
| | | topical heating for the | |
| | | purpose of elevating tissue | |
| | | temperature;<br>the | |
| | | temporary relief of minor | |
| | | muscle and joint pain, | |
| | | | |
| | | arthritis and muscle spasm; | |
| | | relieving | |
| | | promoting the relaxation of | |
| | | muscle tissue;<br>and<br>to | |
| | | temporarily increase local | |
| | | blood circulation where | |
| | | applied. | |
| Structural | Portable | Portable | Same |
| configuration | | | |
| Components | frame,<br>irradiator,<br>Main | Main<br>frame,<br>irradiator, | Same |
| | lifting stand | lifting stand | |
| | | | Similar. |
| Wavelength | | Red 628nm±10nm | Wavelength<br>of |
| | Red light 633±10nm | Blue 420nm±10nm | red<br>and<br>blue |
| | Blue light 417±10nm | Infrared 880nm±10nm | light<br>between |
| | | | KN-7000A and |
| | | | the<br>predicate |
| | | | |
| Power Supply | 100-240V, 50/60Hz±2%, 300VA | 110-120V, 60Hz, 150VA | Similar.<br>The voltage range of KN-7000A is wider than that of the predicate device. |
| Recommended<br>method of<br>therapy | When using pure red, pure blue treatment head alternate irradiation, pure red LEDs irradiates 15 minutes per treatment, pure blue LEDs irradiates 13 minutes per treatment, twice weekly, 8 times per course of treatment; When using red and blue combination treatment head alternate irradiation, red LEDs irradiates 30 minutes per treatment, blue LEDs irradiates 22 minutes per treatment, twice weekly, 8 times per course of treatment. | Twice weekly, 20 minutes per treatment | Similar.<br>Recommended method of therapy of KN-7000A is more specific than that of the predicate device.<br>The time of treatment is related to the irradiance dose, because the irradiance dose of red light and blue light of KN-7000A are same to the predicate device, the difference do not affect the effectiveness and safety. |
| Effective<br>irradiance | Red light 633±10nm<br>Blue light 417±10nm<br>(1)Red head:<br>60mW/cm²±10mW/cm²<br>52J/cm²<br>48W | (1)Red 628nm<br>20W +/- 3W<br>Standard dose 52J/cm²<br>43mW/cm²<br>(2)Blue 420nm<br>10W+/-3W<br>Standard dose 26J/ cm² | Similar.<br>The wavelength of red light and blue light of KN-7000A are slightly different form those of |
| | | | |
| | (2)Blue head:<br>$35mW/cm^2 \pm 10mW/cm^2$<br>$26J/cm^2$<br>28W | 22 mW/cm²<br>(3)Infrared 880nm<br>16W +/- 3W<br>Standard dose 42 J/cm²<br>35mW/cm² | the predicate device.<br>The irradiance dose of red light and blue light of KN-7000A are same to the predicate device, so those differences do not affect the effectiveness and safety. |
| | (3)Red/Blue head:<br>●Red LEDs<br>$30mW/cm^2 \pm 10mW/cm^2$<br>$52J/cm^2$<br>24W<br>●Blue LEDs<br>$20mW/cm^2 \pm 10mW/cm^2$<br>$26J/cm^2$<br>16W | | Similar.<br>The effective irradiance area of KN-7000A is larger than that of the predicate device. The effective irradiance area is related to the size of the treatment head, which does not affect the effectiveness and safety. |
| Effective<br>irradiance area | $800cm^2 \pm 10%$ | $465cm^2 \pm 10%$ | |
| Working<br>distance | 6cm±1cm | 1cm | Same |
| Operation<br>interface | Display screen | Display screen | Same |
| Safety<br>Classification | Class I | Class I | Same |
| Operation<br>Mode | Continuous operation | Continuous operation…