reVive Light Therapy LED Cleansing System

K180447 · Led Technologies, Inc. · OLP · Jun 4, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180447
• Device Name: reVive Light Therapy LED Cleansing System
• Applicant: Led Technologies, Inc.
• Product Code: OLP · General, Plastic Surgery
• Decision Date: Jun 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating mild to moderate inflammatory acne.

Device Story

The reVive Light Therapy® LED Cleansing System is an OTC, handheld LED device for treating mild to moderate inflammatory acne. It utilizes 630nm red and 415nm blue light-emitting diodes. The device is applied directly to the skin by the user; no settings or adjustments are required. Treatment time is 3 minutes. The system includes the LED module, USB power cord, and power adapter. By delivering consistent light energy to the skin, the device aims to reduce acne inflammation. It is intended for home use by patients 13 years or older. The device does not contain user-serviceable components.

Clinical Evidence

Bench testing only. Includes functional performance testing, software validation, and user safety testing. Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10. Thermal performance testing confirmed device temperature remains below 41°C during 30 minutes of continuous use. A usability study with 15 participants demonstrated 100% success in performing the light sensitivity test and device operation.

Technological Characteristics

LED-based light therapy device emitting 630nm (red) and 415nm (blue) light. Powered via USB. Handheld form factor. Complies with IEC 60601-1 (General Safety) and IEC 60601-1-2 (EMC). Biocompatibility per ISO 10993-5 and ISO 10993-10. No user-serviceable parts.

Indications for Use

Indicated for the treatment of mild to moderate inflammatory acne in individuals 13 years of age or older.

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

• Clear Bi-Light (K153081)

Reference Devices

• OmniLux Clear U (K081307)
• BC-001 + Acne Purifier (K170260)
• Nutra Light Blue (K132383)
• Acne Light Therapy Wand (K160691)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 4, 2018

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

Re: K180447

Trade/Device Name: reVive Light Therapy® LED Cleansing System 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 Dated: February 16, 2018 Received: February 20, 2018

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

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## Page 2 - Jelena Barbaric

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# 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

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

510(k) Number (if known) K180447

Device Name reVive Light Therapy® LED Cleansing System

Indications for Use (Describe)

mative Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating mild to moderate inflammatory acne.

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.

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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:

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# 510 (k) Summary

This summary of 510 (k) information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Preparation Date: June 1st, 2018

| 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.

Attn: Lloyd Nelson

6000 Greenwood Plaza Blvd., Suite 110

Greenwood Village, CO, 80111

Tel.: [phone]. Ext 117

Email: [e-mail]

#### 2. General Information

- 2.1 Classification Name: Over-The- Counter Light Based Laser for Acne
- 2.2 Common/usual device name: reVive Light Therapy® LED Cleansing System
- 2.3 Proprietary Names: reVive Light Therapy® LED Cleansing System
- 2.4 Classification: Class II
- 2.5 Classification Number: 878.4810
- 2.6 Product Code OLP
- 2.7 Review Panel: General & Plastic Surgery

#### 3. Device Description

The reVive Light Therapy® LED Cleansing system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The device uses two types of LEDs: 630nm red and 415nm

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blue. The treatment time is controlled by the user. There are no user settings or adjustments required.

The reVive Light Therapy® LED Cleansing System components include the unit containing the LED module, USB power cord, and power adapter.

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 Over the Counter (OTC). It is intended for users 13 years or older.

#### 4. Indications/Intended Use:

The reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) device intended for use in treatment of mild to moderate inflammatory acne.

#### 5. Predicate Device:

This device is substantially equivalent to the following predicates, which are currently in safe and effective commerce under product codes OLP:

#### Primary predicate:

K153081 – Clear Bi-Light (Michael Todd)

Reference predicates: K081307 – OmniLux Clear U K170260 – BC-001 + Acne Purifier K132383 – Nutra Light Blue K160691 – Acne Light Therapy Wand

| Device | reVive Light<br>Therapy® LED<br>Cleansing<br>System<br>K180447 | Clear Bi-Light<br>K153081 | OmniLux<br>Clear U<br>K081307 | BC-001 +<br>Acne Purifier<br>K170260 | Nutra Light<br>Blue<br>K132383 | Acne Light<br>Therapy Want<br>K160691 |
|----------------------|----------------------------------------------------------------|-------------------------------|--------------------------------|--------------------------------------|--------------------------------|---------------------------------------|
| Wavelengths | 415nm,<br>630nm | 405-420nm<br>630-660nm | 415nm,<br>633nm | 415nm<br>660nm | 410nm | 442nm<br>630nm |
| Irradiance<br>source | LED | LED | LED | LED | LED | LED |
| Treatment<br>Area | 18.86 cm² | 20 cm² | 28.7 cm² | 9.1 | 31.6 | 1.594 |
| Treatment<br>Time | 3 minutes per<br>treatment | 3 minutes<br>per<br>treatment | 20 minutes<br>per<br>treatment | 1.5 minutes<br>per area | 3 minutes<br>treatment | 3 minutes per<br>treatment |

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| Type/Class | OTC | OTC | OTC | OTC | OTC | OTC |
|------------|---------|---------|---------|--------|---------|-----|
| | ﺭﺍ ﺍﻟﮑﺎ | رال الا | رال الا | ﺭ ﺍﻟﺤﺎ | رال الا | UIL |
| | | | | | | |

# Predicate Chart

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

- 1. Has the same intended use as the predicate device (I.e., treatment of mild to moderate inflammatory acne);
- 2. Has the similar output (mW/cm²) as predicate devices;
- 3. Utilizes the same/similar treatment duration as the predicate devices;
- 4. Utilizes the similar recommended treatment regimen.

The reVive Light Therapy® LED Cleansing System and the above referenced predicate devices are Over the Counter Devices used to treat acne as defined in 21 CFR § 878.4810. These devices utilize red and blue diodes at 630 and 415 nm for treatment of mild to moderate inflammatory acne. The performance achieved by these devices is comparable with similar 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 reVive Light Therapy® LED Cleansing System has the same intended uses, with similar technological characteristics as predicate devices. The system performs as intended and does not raise any new safety or effectiveness issues.

#### 5. Performance Testing and Standards:

Testing of the reVive Light Therapy® LED Cleansing System, included functional performance testing, software validation, testing, and user safety testing.

Safety and functionality testing demonstrates that the reVive Light Therapy® LED Cleansing System 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,

### Biocompatibility

ISO 10993-5:2009 – Cytotoxicity Test ISO 10993-10:2010 – Intracutaneous reactivity test ISO 10993-10:2010 – Skin Sensitization Test

The reVive Light Therapy® LED Cleansing system software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices".

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A Usability Study was conducted with 15 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.

#### Self-Selection Study

The self-selection study was not conducted, as the box labeling was comparable to that of primary predicate.

#### Thermal Performance Testing

The performance testing was conducted measuring the temperature during the common use of the device. The test results demonstrated that the temperature of the device does not exceed 41C, even after the continuous use for 30 minutes, 10 times longer than the recommended treatment time of 3 minutes.

#### 6. Conclusion

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 subject device and predicate, and no different questions of safety and effectiveness arise. Therefore, the subject device is substantial equivalence to the predicate.