dpl II Panel

K171390 · Led Technologies, Inc. · OHS · Aug 3, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171390
• Device Name: dpl II Panel
• Applicant: Led Technologies, Inc.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Aug 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The dpl® II Panel is an Over-the-Counter (OTC) device intended for use in treating wrinkles.

Device Story

The dpl® II Panel is an OTC LED-based device for wrinkle treatment. It utilizes four LED wavelengths (605nm amber, 630nm red, 660nm red, 880nm infrared) to deliver light energy to the skin. The device consists of a panel unit, power supply, goggles, and storage case. It is operated by the patient at home; the user applies the panel directly to the skin for a 3-minute treatment session. There are no user-adjustable settings. The device provides consistent light administration to the treatment area. By delivering narrow-band light energy, the device aims to reduce the appearance of wrinkles, providing a non-invasive treatment option for patients.

Clinical Evidence

Bench testing only. Performance testing included functional performance, software validation, and user safety testing. The device conforms to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and ISO 10993-10 (biocompatibility). A usability study with 16 participants demonstrated 100% success in performing the light sensitivity test and 100% success in device operation.

Technological Characteristics

LED-based light therapy device. Emits four wavelengths: 605nm, 630nm, 660nm, and 880nm. Irradiance: 70.16 mW/cm². Power source: 120-240V AC adapter. Treatment area: 415 cm². Form factor: Panel unit for direct skin application. Software: Validated per FDA guidance for software in medical devices. Biocompatibility: Tested per ISO 10993-10.

Indications for Use

Indicated for the treatment of wrinkles in individuals using an Over-the-Counter (OTC) device.

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

• dpl® Nuve for Wrinkles (K141181)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

August 3, 2017

LED Technologies, Inc. Jelena Barbaric Compliance Manager 6000 Greenwood Plaza Blvd.. Suite 110 Greenwood Village, Colorado 80111

Re: K171390

Trade/Device Name: dpl II Panel 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: OHS Dated: May 8, 2017 Received: May 11, 2017

Dear Jelena Barbaric:

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 (reporting of medical devicerelated 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/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.

Sincerelv. Jennifer R. Stevenson -23

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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

#### K171390

Device Name dpl® II Panel

Indications for Use (Describe)

The dpl® II Panel system is an Over-the Counter (OTC) device intended for use in treating wrinkles.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

# 510 (k) Summary

This summary of 510 (k) information is being submitted in accordance with the requirements of 21 CFR § 878.4810.

Submission Date: May 8th, 2017

| 1. Submitter Information: | LED Technologies, Inc. - Jelena Barbaric | |
|------------------------------|----------------------------------------------|--|
| | 6000 Greenwood Plaza Blvd., Suite 110 | |
| | Greenwood Village, CO 80111 | |
| | Tel: [phone] | |
| | Email: [e-mail] | |
| For Specification Developer: | LED Technologies, Inc.<br>Attn: Lloyd Nelson | |
| | 6000 Greenwood Plaza Blvd., Suite 110 | |
| | Greenwood Village, CO, 80111 | |
| | Tel.: [phone] | |
| | Email: [e-mail] | |

#### 2. General Information

- 2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction device
- 2.2 Common/usual name: dpl® II Panel
- 2.3 Proprietary Names: dpl® II Panel
- 2.4 Classification: Class II
- 2.5 Classification Number: 878.4810
- 2.6 Product Code OHS
- 2.7 Regulation Medical Specialty: General & Plastic Surgery
- Office of Device Evaluation (ODE) 2.8 Review Panel: Division of Surgical Devices (DSD) General Surgery Device Branch One - Light Based/Laser (GSDB1)

{4}------------------------------------------------

## 3. Device Description

The dpl® II Panel system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles. The device uses four type of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adjustments required.

The dpl® II Panel system components include the panel unit containing the LED module, power supply, goggles, and storage case.

The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Ove The Counter (OTC).

## 4. Indications/Intended Use:

The dpl® II Panel is an Over-the-Counter (OTC) device intended for use in treating wrinkles.

Rx or OTC:

The dpl® II Panel is an Over-the Counter device. The labeling, instructions, and User Operations (21 CFR § 801.60 and 61), are design for layman understanding and use. The predicate device is OTC.

## 5. Predicate Device:

This device is substantially equivalent to the following predicate, which is currently in safe and effective commerce under product code OHS:

K141181 - dpl® Nuve for Wrinkles (LED Technologies, Inc.)

| Device | dpl® II Panel<br>LED Technologies, Inc.<br>KXXXXXXXX<br>This Submission | dpl® Nüve for Wrinkles<br>LED Technologies, Inc.<br>K141181<br>A Predicate Device |
|-------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Indications | The dpl® II Panel is an Over-<br>the-Counter (OTC) device<br>intended for the use in<br>treating wrinkles. | The dpl® Nüve for Wrinkles is<br>an Over-the-Counter (OTC)<br>device intended for the use<br>in treating wrinkles. |
| Wavelengths | 605 nm, 630 nm, 660 nm,<br>880 nm | 605 nm, 630 nm, 660 nm,<br>880 nm |

## Predicate Chart

{5}------------------------------------------------

| Modes | On/Off | On/Off |
|--------------------|----------------------------|----------------------------|
| Irradiance Source | LED | LED |
| Visible light LEDs | Yes | Yes |
| Treatment Area | $415 cm^2$ | $30 cm^2$ |
| Energy Level | $70.16 mW/cm^2$ | $62.07 mW/cm^2$ |
| Power Supply | 120-240V AC Power Adapter | 120-240V AC Power Adapter |
| Treatment Time | 3 minutes per treatment | 3 minutes per treatment |
| Target Population | Individuals with wrinkles. | Individuals with wrinkles. |
| Location for Use | OTC | OTC |

## Summary of the technological characteristics of the device compared to predicate device:

- 1. Has the same intended use as the predicate device (l.e., treatment of wrinkles);
- 2. Has the same/similar output (i.e., 62 mW/cm2) as the predicate device;
- 3. Utilizes the same number of wavelengths (i.e., 4 wavelengths between 605 nm 880 nm) as the predicate device;
- 4. Utilizes the same treatment duration (i.e., 180 seconds) as the predicate device;
- 5. Utilizes the same treatment regimen of five days a week for eight weeks.

The dpl® II Panel system and the above referenced predicate device are Over the Counter Devices used to treat wrinkles as defined in 21 CFR § 878.4810. These devices utilize red and IR diodes between 605 nm to 880 nm to provide narrow bands of light energy to treat wrinkles. The performance achieved by these devices is similar with equal power output. The devices are intended to be placed directly on the skin. They are manufactured out of similar materials. Based upon comparison to the predicate devices, the dpl® II Panel system has the same

{6}------------------------------------------------

intended uses, with similar technological characteristics as the predicate device. The system performs as intended and does not raise any new safety or effectiveness issues.

#### 6. Performance Testing and Standards:

Testing of the dpl® II Panel system, included functional performance testing, software validation, testing, and user safety testing.

Safety and functionality testing demonstrates that the dpl® II Panel conforms to various international consensus standards.

IEC 60601-1: (2006): medical Electrical Equipment part 1: General Requirements for Basic Safety and Essential Performance.

IEC 60601-1-2 (2007): Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Compatibility.

ISO 10993-10:2010 Biological evaluation of medical devices part 10: Tests for irritation and delayed-type hypersensitivity.

The dpl® II Panel system software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices".

A Usability Study was conducted with 16 participants.

The results of the study found that:

100% of the participants were able to demonstrate the light sensitivity test.

100% of the participants were able to use the device successfully.

The conclusions drawn from nonclinical tests demonstrate that the device is safe, as effective, and performs as well as the legally marketed devices.

#### 7. Statement of Safety Effectiveness:

The information in this 510 (k) submission was used to support the safety and effectiveness of this device with respect to its cited properties.

#### 8. Substantial Equivalence Discussion

After analysis of safety, indications, intended uses, dose rates, performance, features, design materials, power output, technological properties, treatment regiment regimens and methods of operation, the manufacturer asserts that no significant differences exist between the applicant device and predicate listed in the predicate chart, and no new issues arise for safety and effectiveness. Therefore, substantial equivalence is hereby requested.