The reVive Light Therapy® Essentials 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 types of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. The reVive Light Therapy® Essentials components include the device containing the LED module. There are no user settings or adjustments required. 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.

AI/ML Overview

The provided FDA 510(k) summary for the reVive Light Therapy® Essentials does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of clinical efficacy (e.g., wrinkle reduction).

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics, safety testing, and usability, which are common for 510(k) submissions for Class II devices.

Here's what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not report specific acceptance criteria for clinical effectiveness (e.g., wrinkle reduction) nor does it provide performance metrics related to such an outcome study. The performance testing mentioned is primarily related to safety, functionality, and software.

Acceptance Criteria (Clinical Efficacy - e.g., Wrinkle Reduction)	Reported Device Performance
Not specified in the document	Not specified in the document
Functional Performance Testing	Device conforms to various international consensus standards (ANSI/AAMI ES 60601-1:2005® + 2012, ANSI/AAMI/IEC 60601-1-2 (2014)).
Software Validation	Software was tested and validated in accordance with FDA guidance.
User Safety Testing	Device conforms to various international consensus standards (ANSI/AAMI ES 60601-1:2005® + 2012, ANSI/AAMI/IEC 60601-1-2 (2014)); Biocompatibility testing (ISO 10993-5, ISO 10993-10) passed.
Usability Study: Correct preparation of device	100% of participants demonstrated correct preparation.
Usability Study: Correct device usage	100% of participants demonstrated correct usage.

Missing Information (for clinical efficacy study):

Specific clinical acceptance criteria (e.g., a certain percentage reduction in wrinkle count, or a statistically significant improvement on a wrinkle severity scale).
Quantitative results demonstrating the device's performance against clinical acceptance criteria.

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

For Usability Study:
- Sample size: 17 participants.
- Data provenance: Not specified, but generally, usability studies are prospective and often conducted in research facilities. The country of origin is not mentioned.
For Clinical Efficacy Study:
- Sample size: Not applicable/not provided, as no clinical efficacy study is detailed.
- Data provenance: Not applicable.

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

For Usability Study: The "ground truth" here is objective observation of user actions. No external experts are mentioned for establishing ground truth; the performance was assessed by the study administrators.
For Clinical Efficacy Study: Not applicable/not provided.

4. Adjudication Method:

For Usability Study: Not explicitly stated as "adjudication," but the results indicate clear observation (100% correct demonstration). This implies direct observation and assessment by the study team.
For Clinical Efficacy Study: Not applicable/not provided.

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

No such study was mentioned in the provided document. The device is a direct-to-consumer light therapy device, not a diagnostic imaging AI algorithm typically subjected to MRMC studies.

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

Not applicable. This device is a physical light therapy device, not an AI algorithm. "Standalone performance" in this context typically refers to the device's physical output and safety, which were tested and found to conform to standards.

7. The Type of Ground Truth Used:

For Usability Study: Observed user behavior against predefined correct procedures.
For Clinical Efficacy Study: Not applicable/not provided.

8. The Sample Size for the Training Set:

Not applicable/not provided. The document describes a physical medical device (LED light therapy) and does not mention any machine learning or AI components requiring a "training set" in the context of typical AI algorithm development.

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

Not applicable/not provided. See point 8.

In summary: The provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence and safety/functionality for a light therapy device. It does not include a detailed clinical efficacy study with specific acceptance criteria, clinical performance metrics, or ground truth establishment relevant to an AI/diagnostic imaging context. The "study" mentioned is a usability study with 17 participants, assessing correct device operation, not clinical outcome.

Summary

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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.

December 15, 2021

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

Re: K210965

Trade/Device Name: reVive Light Therapy Essentials 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: March 29, 2021 Received: March 31, 2021

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.

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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) 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 mediation-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.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210965

Device Name reVive Light Therapy® Essentials

Indications for Use (Describe)

The reVive Light Therapy® Essentials is an Over the Counter (OTC) device intended for treatment of writkles.

Type of Use (Select one or both, as applicable)

| 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 - K210965

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

Submission Date: December 14th, 2021

1. Submitter Information:	LED Technologies, Inc. - Jelena Barbaric
	12821 Starkey Rd., Suite 4900
	Largo, FL 33773
	Tel: 727-285-8300 Ext 203
	Email: jbarbaric@ledtechnologies.com

For Specification Developer: LED Technologies, Inc. Attn: Lloyd Nelson 12821 Starkey Rd., Suite 4900 Largo, FL 33773 Tel.: 727-285-8300. Ext 201 Email: Inelson@ledtechnologies.com

2. General Information

2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction
2.2 Common/usual name: reVive Light Therapy® Essentials
2.3 Proprietary Names: reVive Light Therapy® Essentials
Classification: Class II 2.4
Classification Number: 878.4810 2.5
2.6 Product Code: OHS
2.7 Review Panel: General & Plastic Surgery

3. Device Description

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The reVive Light Therapy® Essentials components include the device containing the LED module.

There are no user settings or adjustments required.

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.

Indications/Intended Use:

The reVive Light Therapy® Essentials is an Over the Counter (OTC) LED device intended for use in treating wrinkles.

Predicate Devices: 4.

K171390 – dpl® II Panel (LED Technologies, Inc.) K180445 – reVive Light Therapy® LED Cleansing System (LED Technologies, Inc.)

Comparison Chart

Device	reVive LightTherapy® EssentialsK210965	dpl® II PanelLED Technologies,Inc.K171390	reVive Light Therapy® LEDCleansing SystemLED Technologies, Inc.K180445
Wavelengths	605nm, 630nm,660nm, 880nm	605nm, 630nm,660nm, 880nm	605nm, 630nm,660nm, 880nm
Irradiancesource	LED	LED	LED
Treatment Area(cm²)	7	415	18.86
Treatment Time	3 minutes pertreatment	3 minutes pertreatment	3 minutes per treatment
Type/Class	OTC	OTC	OTC
IFU	For treatment ofwrinkles	For treatment ofwrinkles	For treatment of wrinkles

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5. Summary of the technological characteristics of the device compared to predicate device:

1. Has the same intended use as the predicate devices (i.e., treatment of wrinkles).
1. Has the similar technical characteristics.
1. Has the same method of operation.
1. Utilizes the same treatment duration as the predicate devices.

The reVive Light Therapy® Essentials and the above referenced predicate devices 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 same with similar power output.

The reVive Light Therapy® Essentials is powered by Batteries) or via Universal USB power source.

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® Essentials 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.

6. Performance Testing and Standards:

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

Safety and functionality testing demonstrate that the reVive Light Therapy® Essentials conforms to various international consensus standards.

ANSI/AAMI ES 60601-1:2005® + 2012 and A1:2012 IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012: Medical Electrical Equipment part 1: General Requirements for Basic Safety and Essential Performance.

ANSI/AAMI/IEC 60601-1-2 (2014): 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

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The reVive Light Therapy® Essentials 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 17 participants.

The results of the study found that:

100% of the participants were able to demonstrate the correct preparation of device for use.

100% of the participants were able to demonstrate correct device usage.

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

7. 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.