The reVive® Perioral LED Light Therapy system is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral region.

Device Description

The reVive® Perioral LED Light Therapy system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for treatment fine lines and wrinkles, and increase in circulation within the perioral region. The device uses four types 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 reVive® Perioral LED Light Therapy system components include the device containing the LED module, USB charging cord, and a storage bag. 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 submission discusses the "reVive® Perioral LED Light Therapy system," an over-the-counter device intended for the treatment of fine lines and wrinkles and to increase circulation in the perioral region. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance data for a standalone device.

Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria (especially regarding efficacy in reducing wrinkles or increasing circulation) is not fully detailed in this document. The document focuses on demonstrating safety and comparable technical characteristics to predicate devices.

However, based on the provided text, here's what can be extracted and inferred regarding performance and safety, framed within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission focused on substantial equivalence, explicit "acceptance criteria" tied to specific clinical efficacy endpoints (e.g., a certain percentage reduction in wrinkle depth) are not provided in the same way they would be for a de novo or PMA submission. Instead, the "acceptance criteria" are implied by demonstrating equivalence to predicate devices and meeting safety standards.

Acceptance Criteria (Implied)	Reported Device Performance (Summary of Technical Characteristics from Predicate Chart)
Safety: Device operates safely according to electrical, EMC, and biocompatibility standards.	Electrical Safety: Conforms to IEC 60601-1:2012.
	EMC: Conforms to IEC 60601-1-2:2014.
	Battery Safety: UL 1642 & UN 38.3 certified.
	Biocompatibility: Conforms to ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Intracutaneous reactivity), ISO 10993-10 (Skin Sensitization).
	Usability: 100% of 15 participants able to demonstrate light sensitivity test and use the device successfully.
Similar Technical Characteristics to Predicates (demonstrating comparable performance for intended use):
Wavelengths used are similar to predicates.	605nm, 630nm, 660nm, 880nm (same as all predicates).
Irradiance source is similar to predicates.	LED (same as all predicates).
Energy level is similar to predicates.	67.7 mW/cm² (comparable to predicates ranging from 61.59 to 70.16 mW/cm²).
Treatment time is similar to predicates.	3 minutes per treatment (same as all predicates).
Treatment regimen is similar to predicates.	Five days a week for eight weeks (same as predicates).
Materials used are similar/same as predicates.	"Materials used for the device are similar to what is used in the dpl® Nüve & dpl® II Panel, and same as used in dpl® SpectraLite."
Device type/class is the same as predicates.	OTC (same as all predicates).
Intended use is same/similar to predicates.	Treatment of fine lines and wrinkles, and increase in circulation within the perioral region (similar to predicates for wrinkle treatment).

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

The document describes a "Usability Study" as the primary user-facing test.

Sample Size: 15 participants.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, usability studies are generally prospective.

The performance characteristics cited (e.g., wavelengths, energy levels) are inherent design parameters of the device, not results from a "test set" in the context of clinical efficacy demonstration here.

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

This information is not provided in the document. The Usability Study likely involved observers or researchers assessing participant interactions, but the document does not specify experts establishing ground truth for efficacy. For the safety tests (IEC, ISO, UL), the "ground truth" is adherence to those established international standards.

4. Adjudication Method for the Test Set

This information is not provided. For the Usability Study, it's not clear if there was any formal adjudication beyond observation of task completion.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically associated with diagnostic imaging devices evaluating human reader performance with and without AI assistance, which is not applicable to an LED light therapy device for wrinkle reduction.

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

This concept is not directly applicable to this device. The reVive® Perioral LED Light Therapy system is a physical therapy device; it does not involve an "algorithm only" component or human interpretation of outputs in the way an AI diagnostic tool would. Its performance is its direct physical output (light therapy). The "Usability Study" evaluates human interaction with the physical device, not an algorithm's standalone performance.

7. The Type of Ground Truth Used

For the safety and performance characteristics, the "ground truth" is adherence to:

Established international and national consensus standards (IEC, UL, ISO) for electrical safety, electromagnetic compatibility, battery safety, and biocompatibility.
The manufacturer's design specifications for parameters like wavelength, energy level, and treatment time.
For the Usability Study, the "ground truth" implicitly was the successful completion of tasks (light sensitivity test, device usage) by participants.

There is no mention of "expert consensus, pathology, or outcomes data" as ground truth for clinical efficacy in this 510(k) summary. The submission relies on substantial equivalence to legally marketed devices for efficacy claims.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. A "training set" typically refers to data used to train an artificial intelligence or machine learning algorithm. This device is a hardware-based light therapy system, not an AI/ML product.

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

This information is not provided and is not applicable for the reasons stated above (not an AI/ML product).

Summary

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January 9, 2018

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

Re: K172662

Trade/Device Name: reVive Perioral LED Light Therapy 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. ILY Dated: October 12, 2017 Received: October 12, 2017

Dear Ms. 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, 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 - Ms. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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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Indications for Use

510(k) Number (if known) K172662

Device Name

The reVive® Perioral LED Light Therapy system

Indications for Use (Describe)

Indications for Use (Describe)
The reVive® Perioral LED Light Therapy system is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral region.

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 § 878.4810.

Submission Date: August 31st, 2017

Preparation Date: January 9th, 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 11
	Greenwood Village, CO, 80111
	Tel.: 303-407-6884
	Email: Inelson@ledtechnologies.com

2. General Information

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

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3. Device Description

The reVive® Perioral LED Light Therapy system components include the device containing the LED module, USB charging cord, and a storage bag.

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® Perioral LED Light Therapy system is an Over-the-Counter (OTC) device intended for the treatment fine lines and wrinkles, and increase in circulation within the perioral region.

5. Predicate Devices:

This device is substantially equivalent to the following predicate, which is currently legally marketed under product code OHS:

K141181 dpl® Nuve for wrinkles (LED Technologies, Inc.) ●
K171390 dpl® II Panel (LED Technologies, Inc.) ●
K171386 dpl® SpectraLite (LED Tchnologies, Inc.) ●

Predicate Chart

Device	reVive® PerioralLED Light TherapysystemLED Technologies,Inc.KXXXXXXXXX	dpl® Nüve forwrinklesLED Technologies,Inc.K141181	dpl® II PanelLED Technologies,Inc.K171390	dpl® SpectraLiteLED Technologies,Inc.K171386
Wavelengths	605nm, 630nm,660nm, 880nm	605nm, 630nm,660nm, 880nm	605nm, 630nm,660nm, 880nm	605nm, 630nm,660nm, 880nm
Irradiance source	LED	LED	LED	LED
Treatment Area	24 cm²	30 cm²	415 cm²	28 cm²
Energy Level	67.7 mW/cm²	62.07 mW/cm²	70.16 mW/cm²	61.59 mW/cm²

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Treatment Time	3 minutes per treatment	3 minutes per treatment	3 minutes per treatment	3 minutes per treatment
Type/Class	OTC	OTC	OTC	OTC

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

1. Has the same/similar intended use as the predicate device (i.e., treatment of wrinkles).
1. Has the same/similar output (i.e., 67.7 mW/cm²) as the predicate devices;
1. Utilizes the same number of wavelengths (i.e., 4 wavelengths between 605 nm 880 nm) as the predicate devices;
1. Utilizes the same treatment duration (i.e., 180 seconds) as the predicate devices;
1. Utilizes the same treatment regimen of five days a week for eight weeks.

The reVive® Perioral LED Light Therapy system 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 similar with equal power output. Based upon comparison to the predicate devices, the reVive® Perioral LED Light Therapy system has the same intended uses, and similar technological characteristics as the predicate devices.

The devices are intended to be placed directly on the skin. The materials used for the device are similar to what is used in the dpl® Nüve & dpl® II Panel, and same as used in dpl® SpectraLite.

The reVive® Perioral LED Light Therapy system is battery powered (LI-Ion Battery 5V USB & 3.7 V Battery). Battery is charged via Universal USB charger cord. The change in energy (the addition of battery) is usually part of a redesign to provide a portable version of a predicate device. The indication for use does not change. Operation of device does not change. The system performs as intended and does not raise any new safety or effectiveness issues.

6. Performance Testing and Standards:

Testing of the reVive® Perioral LED Light Therapy system, included functional performance testing, and software validation testing.

Safety and functionality testing demonstrates that the reVive® Perioral LED Light Therapy system conforms to various international consensus standards.

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IEC 60601-1: 2012: Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance.

IEC 60601-1-2: 2014: Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Compatibility.

UL 1642 Battery Certification UN 38.3 Battery Certification.

Biocompatibility

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

The reVive® Perioral LED Light Therapy 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 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.

7. Substantial Equivalence Discussion

After analysis of, indications, intended uses, dose rates, performance, features, design materials, power output, technological properties, treatment areas, treatment 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.