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 wrinkles and mild to moderate inflammatory acne, as defined in 21 CFR § 878.4810. In addition to the LED light therapy treatment function, reVive Light Therapy® LED Cleansing System has a separate function for cleansing. The system includes two cleansing brush-heads, constructed of TPE material. The reVive Light Therapy® LED Cleansing System components include the device 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).

AI/ML Overview

This document describes a 510(k) premarket notification for the reVive Light Therapy® LED Cleansing System (K221430). It establishes substantial equivalence by comparing the new device to two predicate devices (K180445 and K180447).

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for clinical performance (e.g., specific reduction percentages for wrinkles or acne severity scores). Instead, it relies on demonstrating that the modified device performs "as well as the legally marketed devices" and meets "product system requirements, which is based on the predicate devices."

The table below summarizes the comparison of technological characteristics between the new device and its predicates, which forms the basis of the performance claim.

Feature	Predicate Device K180445 (Wrinkle Treatment)	Predicate Device K180447 (Acne Treatment)	New Device K221430 (Wrinkle & Acne Treatment)	Implied Acceptance Criteria	Reported Device Performance (K221430)
Wavelengths	605nm, 630nm, 660nm, 880nm	415nm, 630nm	Wrinkle Treatment: 605nm, 630nm, 660nm, 880nmAcne Treatment: 415nm, 630nm	Wavelengths should match or encompass those of relevant predicates for respective indications.	Wrinkle Treatment: Matches K180445.Acne Treatment: Matches K180447. (All stated to be identical.)
Irradiance Source	LED	LED	LED	LED technology should be used.	LED (Identical to predicates).
Treatment Area	18.86 cm²	18.86 cm²	18.86 cm²	Treatment area should be 18.86 cm².	18.86 cm² (Identical to predicates).
Treatment Method	Place device directly on the skin	Place device directly on the skin	Place device directly on the skin	Device should be applied directly to the skin.	Place device directly on the skin (Identical to predicates).
Treatment Time	3 minutes	3 minutes	3 minutes	Treatment duration should be 3 minutes.	3 minutes (Identical to predicates).
Material	ABS	ABS	ABS	Material should be ABS.	ABS (Identical to predicates).
Power Source	3.7 V Lithium Battery	3.7 V Lithium Battery	3.7 V Lithium Battery	Power source should be 3.7 V Lithium Battery.	3.7 V Lithium Battery (Identical to predicates).
Type/Class	OTC	OTC	OTC	Device should be Over-The-Counter (OTC).	OTC (Identical to predicates).
IFU	Treatment of wrinkles	Treatment of mild to moderate inflammatory acne	Treatment of wrinkles and mild to moderate inflammatory acne	Should cover wrinkles (like K180445) and acne (like K180447).	Covers both wrinkles and mild to moderate inflammatory acne (combines IFUs of both predicates).

Study Proving Acceptance Criteria:

The document describes a study that aimed to confirm that the modifications made to the device were "correctly implemented and that the device performs as well as the legally marketed devices." The study focused on software testing and validation:

Study Name/Description: The specific name of the study is not given, but it is described as "Testing" in Section 6.
Methodology: 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."
Conclusion: The testing "confirmed that modifications made to the device were correctly implemented and that the device performs as well as the legally marketed devices."

Important Note: This submission is a 510(k) for a modified device, leveraging existing predicates. Clinical studies demonstrating efficacy for wrinkles and acne are implied to have been conducted for the original predicate devices, not extensively for this specific modification, which primarily involves updated software and associated hardware while maintaining the fundamental scientific technology and parameters.

Here's the breakdown for the additional information requested, based on the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document states "The reVive Light Therapy® LED Cleansing system software was tested and validated..." but does not provide details on the number of test cases, subjects, or data points used during this software testing and validation.
Data Provenance: Not specified. There is no mention of the origin (e.g., country) of any data used for testing, nor whether it was retrospective or prospective. Given it's a software validation for a hardware modification, it's likely internal testing without external patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. The document describes software testing and validation for a device modification, not a clinical study requiring expert ground truth for diagnostic or therapeutic outcomes on patients. The "ground truth" here would likely be defined by engineering and software requirements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of images or symptoms by multiple experts. This documentation focuses on software and hardware verification against established design specifications and predicate performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. A multi-reader, multi-case comparative effectiveness study (MRMC) was not conducted or reported in this document. This device is an LED therapy system for direct use, not an AI-assisted diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not an AI algorithm in the context of diagnostic or interpretive tools; it's an LED therapy device with software controls. The "standalone" performance here refers to the device's functional integrity as a light therapy system. The document states that "Testing confirmed that modifications made to the device were correctly implemented and that the device performs as well as the legally marketed devices." This implies testing of the device's operational parameters (light output, timing, power, etc.) in a standalone capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the software testing and validation mentioned, the "ground truth" would be the design specifications and functional requirements of the device's software and hardware, as well as the established performance of the predicate devices. It is not clinical ground truth like pathology or patient outcomes for this specific submission, but rather adherence to engineering and safety standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI algorithm in the context of a "training set." The device is a physical light therapy product.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this submission.

Summary

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July 27, 2022

LED Technologies, Inc. Jelena Barbaric Compliance Manager 12821 Starkey Rd., Suite 4900 Largo, Florida 33773

Re: K221430

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: OHS, OLP Dated: July 13, 2022 Received: July 15, 2022

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 801and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221430

Device Name reVive Light Therapy® LED Cleansing System

Indications for Use (Describe) The reVive Light Therapy LED Cleansing System is intended for treatment of wrinkles and mild to moderate inflammatory acne.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (k) Summary K221430

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

Submission Date: May 17th, 2022

1. Submitter Information: LED Technologies, Inc. - Jelena Barbaric 12821 Starkey Rd., Suite 4900 Largo, FL 33773 Tel: 303-845-0028 Email: jbarbaric@ledtechnologies.com
  For Specification Developer: LED Technologies, Inc. Attn: Lloyd Nelson 12821 Starkey Rd., Suite 4900 Largo, FL 33773 Tel.: 303-748-0545 Email: Inelson@ledtechnologies.com

2. General Information

2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction/Over-The-Counter Light-Based Laser for Acne
2.2 Common/usual 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: OHS/OLP
2.7 Review Panel: General & Plastic Surgery

3. Device Description

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In addition to the LED light therapy treatment function, reVive Light Therapy® LED Cleansing System has a separate function for cleansing. The system includes two cleansing brush-heads, constructed of TPE material.

The reVive Light Therapy® LED Cleansing System components include the device 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).

4. Indications/Intended Use

The reVive Light Therapy® LED Cleansing System is intended for treatment of wrinkles and 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 OHS/OLP:

K180445 - The reVive Light Therapy® LED Cleansing System (LED Technologies, Inc.)

K180447 – The reVive Light Therapy® LED Cleansing System (LED Technologies, Inc.)

	New DeviceK221430	Predicate DeviceK180445	Predicate DeviceK180447
Wavelengths	Wrinkle Treatment:605nm630nm660nm880nmAcne Treatment:415nm630nm	605nm630nm660nm880nm	415nm630nm
IrradianceSource	LED	LED	LED
TreatmentArea	18.86 cm²	18.86 cm²	18.86 cm²
TreatmentMethod	Place device directlyon the skin	Place device directly onthe skin	Place device directlyon the skin
TreatmentTime	3 minutes	3 minutes	3 minutes

Comparison Chart

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Material	ABS	ABS	ABS
Power Source	3.7 V Lithium Battery	3.7 V Lithium Battery	3.7 V Lithium Battery
Type/Class	OTC	OTC	OTC
IFU	Treatment ofwrinkles and mild tomoderateinflammatory acne	Treatment of wrinkles	Treatment of mild tomoderateinflammatory acne

6. Testing

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".

The Testing confirmed that modifications made to the device were correctly implemented and that the device performs as well as the legally marketed devices.

7. Conclusion

In sum, the only modification introduced is the updated software and associated hardware. All other features including the technological characteristics, material, treatment method, treatment time, and the intended uses of a new device are identical to that of the cleared devices. The introduced modification does not present changes to the fundamental scientific technology and essential parameters of the originally cleared predicate devices.

Testing confirmed that the performance of the reVive Light Therapy® LED Cleansing System meets the product system requirements, which is based on the predicate devices. Therefore, the modification resulted in a device that performs the same as the predicate devices.

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.