K Number

Device Name

Photodynamic Therapy Device

Manufacturer

UVBIOTEK, LLC

Date Cleared

2017-07-28

(186 days)

Product Code

GEX

Regulation Number

878.4810

Intended 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 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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K083183

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a light therapy device with specific wavelengths and does not mention any AI or ML components or functionalities.

Therapeutic

Yes
The device is described as treating "dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris," which is a therapeutic purpose.

Diagnostic

No.
The device is described as a "Photodynamic Therapy Device" intended to "treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris" by emitting light. Its purpose is therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs)" and is "mainly made up of the main frame, the irradiator, and the lifting stand," indicating it is a hardware device that emits light.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris." This is a therapeutic treatment applied directly to the patient's skin.
Device Description: The device uses light (LEDs) to treat a condition on the body.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. IVDs are used for diagnosis, not direct treatment.

The device described is a therapeutic device used for photodynamic therapy to treat acne.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

GEX

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 following testing was performed on the "KN-7000A" Photodynamic Therapy Device in accordance with the requirements of the design control regulations and established quality assurance procedures.

AAMI/ANSI ES60601-1: 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2007 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC 60601-2-57:2011 Medical Electrical Equipment-Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

Thermal performance test were carried out on human volunteers to show that skin temperature stays below 41 degrees C after 20 minutes of use.

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K083183 Aklarus Phototherapy System

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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)

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: DOberhelman@medteklighting.com Telephone: 518-747-3310 Fax: 518-747-2294

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 2016@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549

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

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.

6. Intended Use of Device

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
Name	Photodynamic Therapy
Device	Aklarus Phototherapy
System	-----
Model	KN-7000A	Aklarus Phototherapy
System	-----
Manufacturer	Xuzhou Kernel Medical
Equipment Co., Ltd.	Hill Laboratories	-----
Indications for
use	The Photodynamic Therapy
Device combination of Red
(633nm $\pm$ 10nm) and Blue
(417nm $\pm$ 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.	The Aklarus Blue (420nm
$\pm$ 10nm), is generally
indicated to treat
dermatological conditions
and specifically indicated
to treat moderate
inflammatory acne
vulgaris.
The Aklarus combination
of Red (628nm $\pm$ 10nm)
and Blue (420nm $\pm$ 10nm)	Same. The
indications for
use of
KN-7000A are
contained in
those of the
predicate
device.

		is intended to emit energy
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;
the
		temporary relief of minor
		muscle and joint pain,

		arthritis and muscle spasm;
		relieving
		promoting the relaxation of
		muscle tissue;
and
to
		temporarily increase local
		blood circulation where
		applied.
Structural	Portable	Portable	Same
configuration
Components	frame,
irradiator,
Main	Main
frame,
irradiator,	Same
	lifting stand	lifting stand
			Similar.
Wavelength		Red 628nm±10nm	Wavelength
of
	Red light 633±10nm	Blue 420nm±10nm	red
and
blue
	Blue light 417±10nm	Infrared 880nm±10nm	light
between
			KN-7000A and
			the
predicate

Power Supply	100-240V, 50/60Hz±2%, 300VA	110-120V, 60Hz, 150VA	Similar.
The voltage range of KN-7000A is wider than that of the predicate device.
Recommended
method of
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.
Recommended method of therapy of KN-7000A is more specific than that of the predicate device.
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
irradiance	Red light 633±10nm
Blue light 417±10nm
(1)Red head:
60mW/cm²±10mW/cm²
52J/cm²
48W	(1)Red 628nm
20W +/- 3W
Standard dose 52J/cm²
43mW/cm²
(2)Blue 420nm
10W+/-3W
Standard dose 26J/ cm²	Similar.
The wavelength of red light and blue light of KN-7000A are slightly different form those of

	(2)Blue head:
$35mW/cm^2 \pm 10mW/cm^2$
$26J/cm^2$
28W	22 mW/cm²
(3)Infrared 880nm
16W +/- 3W
Standard dose 42 J/cm²
35mW/cm²	the predicate device.
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:
●Red LEDs
$30mW/cm^2 \pm 10mW/cm^2$
$52J/cm^2$
24W
●Blue LEDs
$20mW/cm^2 \pm 10mW/cm^2$
$26J/cm^2$
16W		Similar.
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
irradiance area	$800cm^2 \pm 10%$	$465cm^2 \pm 10%$
Working
distance	6cm±1cm	1cm	Same
Operation
interface	Display screen	Display screen	Same
Safety
Classification	Class I	Class I	Same
Operation
Mode	Continuous operation	Continuous operation	Same
Standard	IEC60601-1
IEC60601-1-2
IEC60601-2-57	IEC60601-1
IEC60601-1-2
IEC60601-2-57
IEC62471	Same
Non- sterile	Non- sterile	Non- sterile	Same
Microprocessor
Control	Yes	Yes	Same

Table 1

UVBIOTEK, LLC

8. Substantial Equivalence:

The proposed device of KN-7000A has the same classification information, same indications and intended use, same design principle, similar product design and specifications, same irradiance dose of red light and blue light, same performance effectiveness, performance safety as the predicate device.

The differences only exist in such main contents: Wavelength of red and blue light between KN-7000A and the predicate device are slightly different. The effective irradiance area of KN-7000A and the predicate device is different. The two recommended method of therapy are different. The voltage range of KN-7000A is wider than that of the predicate device. These differences do not influence the effectiveness and safety of the device. According to the nonclinical and clinical test results, the proposed device is as effective and perform as well as the predicate device. Therefore the proposed device is Substantially Equivalent (SE) to the predicate device.

9. Performance Data:

The following testing was performed on the "KN-7000A" Photodynamic Therapy Device in accordance with the requirements of the design control regulations and established quality assurance procedures.

AAMI/ANSI ES60601-1: 2005/(R)2012 and A1:2012,, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance

IEC60601-1-2:2007 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC60601-2-57:2011 Medical Electrical Equipment-Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

Thermal performance test were carried out on human volunteers to show that skin temperature stays below 41 degrees C after 20 minutes of use.

10. Conclusion:

Based upon the performance data, the subject device is determined to be substantially equivalent to the predicate device.

--- End of this section ---