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 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.

AI/ML Overview

The provided FDA 510(k) summary for the reVive Light Therapy® LED Cleansing System (K180447) does not contain a typical acceptance criteria table with reported device performance metrics in the way a clinical study for diagnostic or prognostic devices would.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Clear Bi-Light K153081) through comparison of technological characteristics and performance testing related to safety and functionality. The "acceptance criteria" can be inferred from the comparisons made to the predicate device and the pass/fail nature of the safety and usability tests.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since there isn't a direct table in the document, I will construct one based on the information provided, inferring acceptance criteria from the comparisons to the predicate and the documented test results.

Acceptance Criterion (Inferred from Predicate Comparison/Safety Standards)	Reported Device Performance (reVive Light Therapy® LED Cleansing System)
Technological Characteristics
Same intended use as predicate	Treatment of mild to moderate inflammatory acne
Similar output (mW/cm²) as predicate devices	"Similar output (mW/cm²) as predicate devices" (Specific value not provided for reVive Light Therapy® LED Cleansing System in this document, but deemed similar)
Same/similar treatment duration as predicate devices	3 minutes per treatment
Similar recommended treatment regimen	"Similar recommended treatment regimen"
Wavelengths (comparison to predicate)	415nm, 630nm
Irradiance source (comparison to predicate)	LED
Treatment Area (comparison to predicate)	18.86 cm²
Safety and Functionality
Conformance to IEC 60601-1 (Basic Safety & Essential Performance)	Conforms to standard
Conformance to IEC 60601-1-2 (EMC)	Conforms to standard
Conformance to ISO 10993-5 (Cytotoxicity)	Conforms to standard (Biocompatibility tests passed)
Conformance to ISO 10993-10 (Intracutaneous reactivity)	Conforms to standard (Biocompatibility tests passed)
Conformance to ISO 10993-10 (Skin Sensitization)	Conforms to standard (Biocompatibility tests passed)
Software validation per FDA guidance	Software tested and validated
Light sensitivity test demonstrated by users	100% of participants able to demonstrate light sensitivity test
Successful device use by users	100% of participants able to use the device successfully
Device temperature during continuous use (not exceeding 41C)	Does not exceed 41°C, even after 30 minutes continuous use

2. Sample Size Used for the Test Set and Data Provenance

Usability Study Test Set: 15 participants.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This was a usability study, often conducted in a controlled environment, likely in the US where the submitter is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to the studies presented for this device.

For the usability study, "ground truth" was about successful execution of tasks and demonstrating light sensitivity, not clinical diagnosis. The performance was measured by participant action, not expert judgment.
For the safety and functional performance testing, "ground truth" was established by adherence to international standards (e.g., IEC, ISO) and internal testing protocols, not by expert consensus on clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The usability study involved observing participants' actions (e.g., "100% of the participants were able to demonstrate the light sensitivity test."). Safety and performance tests against standards have pass/fail criteria, not adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study is for diagnostic devices where human readers interpret medical images or data. The reVive Light Therapy® LED Cleansing System is a direct treatment device, not a diagnostic tool requiring human interpretation with or without AI assistance.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

Yes, in a sense. The "performance testing" described (functional performance testing, software validation, safety testing, thermal performance testing) essentially represents standalone performance of the device's physical and software aspects against defined specifications and standards, without real-time human intervention influencing its core operation during the test.

7. The Type of Ground Truth Used

Usability Study: User performance metrics (ability to demonstrate a test, successful device use).
Safety and Functional Testing: Adherence to established international consensus standards (IEC, ISO) and internal performance specifications (e.g., thermal limits, software functionality).
Substantial Equivalence: Comparison to the technological characteristics, intended use, and treatment parameters of a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is an LED therapy system, not an AI/machine learning algorithm that requires a training set in the typical sense. The software validation is likely for operational logic and safety features, not for learning from data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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: 303-407-6882
	Email: jbarbaric@ledtechnologies.com

For Specification Developer: LED Technologies, Inc.

Attn: Lloyd Nelson

6000 Greenwood Plaza Blvd., Suite 110

Greenwood Village, CO, 80111

Tel.: 303-646-0543. Ext 117

Email: Inelson@ledtechnologies.com

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

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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 LightTherapy® LEDCleansingSystemK180447	Clear Bi-LightK153081	OmniLuxClear UK081307	BC-001 +Acne PurifierK170260	Nutra LightBlueK132383	Acne LightTherapy WantK160691
Wavelengths	415nm,630nm	405-420nm630-660nm	415nm,633nm	415nm660nm	410nm	442nm630nm
Irradiancesource	LED	LED	LED	LED	LED	LED
TreatmentArea	18.86 cm²	20 cm²	28.7 cm²	9.1	31.6	1.594
TreatmentTime	3 minutes pertreatment	3 minutespertreatment	20 minutespertreatment	1.5 minutesper area	3 minutestreatment	3 minutes pertreatment

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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);
1. Has the similar output (mW/cm²) as predicate devices;
1. Utilizes the same/similar treatment duration as the predicate devices;
1. 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.

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.