The Elevare Plus is an over-the-counter, battery powered, hand-held light emitting diode (LED) device that emits light energy in the red and I/R spectrum for the treatment of wrinkles on the face. The system components include the handheld unit containing the LED array, 2 Li-ion rechargeable batteries, power adapter, charging cord, charging cradle and travel case.

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

The provided text does not contain information about acceptance criteria or a study that proves the device meets the acceptance criteria in the way typically found for AI/ML medical devices. The document is a 510(k) summary for a light-based device (Elevare Plus) intended for wrinkle reduction, and its focus is on demonstrating substantial equivalence to predicate devices based on safety and performance testing, rather than a clinical study with detailed performance metrics against a defined acceptance criterion.

However, I can extract the relevant information from the document that pertains to how the device's performance was evaluated and compared, even if it doesn't align perfectly with the structure requested for AI/ML device studies.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical efficacy endpoints or statistical thresholds for AI/ML performance. Instead, it demonstrates performance through technical specifications and comparison to predicate devices. The "acceptance criteria" are implied to be meeting technical specifications and demonstrating "substantial equivalence" to other legally marketed devices.

Acceptance Criteria (Implied)	Reported Device Performance
Conformity to Electrical Safety Standards	IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012 (Medical Electrical Equipment) Met.
Conformity to EMC Standards	IEC 60601-1-2 Edition 4: 2014 (Electromagnetic Disturbances) Met.
Conformity to Biocompatibility Standards	ISO 10993-1:2009/(R) 2013, ISO 10993-5:2009/(R) 2014, ISO 10993-10 Third Edition 2010-08-01 (Biological Evaluation) Met.
Conformity to Photobiological Safety Standards	IEC 62471 First Edition 2006-07 (Photobiological Safety) Met.
Conformity to Home Healthcare Environment Standards	IEC 60601-1-11 Edition 2.0 2015-01 (Home Healthcare Environment) Met.
Software Validation	Software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
Skin Temperature (within 41+/- 2 ºC and not above 43 ºC)	Two devices tested; temperatures recorded every 1 minute for up to 30 minutes. Test results concluded the device was within specification of 41+/- 2 ºC and did not elevate skin temperature above 43ºC under nominal use conditions (continuous movement).
Wavelength/Power Output (meets specifications)	Tested for Radiant Flux (Output energy, W) and Output energy Spectral distribution (W/nm) to ensure product meets specifications. (Specific values not provided in this summary, but confirmed to be within specification.)
Substantial Equivalence to Predicate Devices (overall technical characteristics and safety/efficacy)	Evaluation testing compared the Elevare Plus to several FDA cleared devices with the same indications for use. Conclusion: "the Elevare Plus device is substantially equivalent to other legally marketed devices" based on: same indications, treatment time, regime; similar infrared wavelength to reference devices; differences in number of LEDs/treatment surface/power output don't affect safety/efficacy.

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

Test Set Sample Size: For "Skin Temperature Testing", two devices were tested. For "Predicate Comparison Testing," "several FDA cleared devices" were evaluated against the Elevare Plus device. No other specific sample sizes for testing are mentioned.
Data Provenance: The testing appears to be prospective bench testing and performance testing conducted by the manufacturer specifically for this submission. The origin of the data (country) is not explicitly stated but is implied to be part of the manufacturer's testing efforts.

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

This type of information is generally not applicable to a submission for a physical device like the Elevare Plus, which relies on technical performance and safety testing rather than interpretation of data by human experts for ground truth. The "ground truth" here is defined by physical measurements against established engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. The testing described involves objective measurements against established standards, not interpretation or adjudication by multiple human readers.

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

No. An MRMC study is relevant for assessing the diagnostic performance of an AI system, often comparing AI-assisted vs. unassisted human performance. This document describes the safety and engineering performance of a physical light therapy device, not an AI/ML diagnostic algorithm.

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

This refers to AI/ML algorithm performance. The Elevare Plus is a physical device, not an AI/ML algorithm, so this concept is not applicable.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation described in this summary consisted of:

International consensus standards for electrical safety, EMC, biocompatibility, photobiological safety, and home healthcare environments.
Manufacturer's internal specifications for software validation, skin temperature limits (41+/- 2 ºC, not above 43ºC), and wavelength/power output.
Technical characteristics and documented performance of legally marketed predicate and reference devices (as detailed in their 510(k) summaries) for comparison purposes to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The Elevare Plus is a physical light therapy device, not an AI/ML algorithm that requires a "training set."

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

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

Summary

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June 7, 2018

Omm Imports d/b/a Zero Gravity % Susan Anthoney-Dewet FDA Consultant Aegis, Inc 2424 Dempster Dive Coralville, Iowa 52241

Re: K172909

Trade/Device Name: Elevare Plus 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: August 30, 2017 Received: September 25, 2017

Dear Susan Anthoney-Dewet:

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

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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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Indications for Use

510(k) Number (if known) K172909

Device Name ELEVARE PLUS

Indications for Use (Describe)

The Elevare Plus is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

K172909

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

Submission Date: December 15, 2016

1. Submitter Information: AEGIS Regulatory, Inc. – Susan Anthoney-DeWe2424 Dempster DriveCoralville, IA 52241Tel.: 865-982-5552Email: sue@fdalistingconsultants.com
On behalf of Sponsor: Omm Imports, Inc. d/b/a Zero Gravity9737 NW 41st Street STE 234Doral, FL 33178

2. General Information

2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction Device
2.2 Common/Usual Name: Red/IR Light Therapy Device
2.3 Proprietary Names: Elevare Plus
2.4 Classification: Class II
2.5 Classification Number: 878.4810
2.6 Product Code: OHS
2.7 Regulation Medical Specialty: General & Plastic Surgery
2.8 Review Panel: Office of Device Evaluation (ODE) Division of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1)

3. Predicate Device(s):

Predicate Device: K141181 -NUVE for Wrinkles (LED Technologies, LLC)

Reference Devices:

1. K120775 LightStim for Wrinkles (LED Intellectual)
1. K120560- Trinity Wrinkle Remover (Carol Cole Company)

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4. Device Description:

5. Indications / Intended Use:

The Elevare Plus is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.

6. Comparison Of Technological Characteristics With The Predicate Device:

	Predicate Comparison Chart
Device	ElevarePlus	NUVE forWrinkles	LightStim forWrinkles	Trinity WrinkleRemover
	OmmImports,Inc. d/b/aZeroGravity	LEDTechnologies,LLC	LED Intellectual	Carol ColeCompany
	K172909	K141181	K120775	K120560
	ThisSubmission	A PredicateDevice	A ReferenceDevice	A ReferenceDevice
Indications	The Elevare+ is an Over-the-Counter(OTC) deviceintended forthe use intreatingwrinkles onthe face.	The Nüve forWrinkles is anOver-the-Counter(OTC) deviceintended for theuse in treatingfull-facewrinkles.	The Lightstim forWrinkles is anOTC hand-helddevice intendedfor the use in thetreatment of full-face wrinkles	The TrinityWrinkle Removeris an OTC hand-held deviceintended for usein the treatmentof full-facewrinkles
Anatomical Sites	Entire Face	Entire Face	Entire Face	Entire Face
Handheld	Yes	Yes	Yes	Yes
Wavelengths	610, 630,660, 850nm	605,630,660,880	605,630,660,855n	605,628,642,850n
	+/- 5nm	nm	m	m
Safety Features	Skin ContactSensor, Fan,Temperature Sensor, in-activitytimer	Unknown	Unknown	unknown
Irradiance source	LED	LED	LED	LED
Visible light LEDs	Yes	Yes	Yes	Yes
LEDArray/Arrangement	25 LEDsOver 17 cm2	60 LEDs. Over30cm2	72 LEDs. Over40cm2	36 LEDs. Over1.25"D
Energy Level	65 mW total	65 mW total	65 mW total	Unknown
(mW/cm2)	(+/- 5 mW)	(in 510kSummary)	(in 510kSummary)
Power Supply	2 Li-Ionrechargeablebatteries	28v DC powersupply	9-volt DC powertransformer	4 rechargeablebatteries
Treatment Time	3 minutesdaily, 5 daysper week for8 weeks	3 minutes daily, 5days per weekfor 8 weeks	3 minutes daily, 5days per week for8 weeks	3 minutes eacharea, 21 minutestotal minimum 5days per week for8 weeks
Target Population	Individualswithwrinkles onthe face	Individuals withwrinkles on theface	Individuals withwrinkles on theface	Individuals withwrinkles on theface
Location for Use	OTC	OTC	OTC	OTC

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

The Elevare Plus has the same indications for use, treatment time, and treatment regime as the predicate device. The proposed device uses a different infrared wavelength than the predicate device, however the sponsor's use of the 850nm is identical to the reference devices K120775 (LightStim for Wrinkles) and within +/- 5nm to the reference device K120560- (Trinity Wrinkle Remover). The sponsor is certain that the difference in number of LEDs, treatment surface area, and slightly different power output does not affect the safety or efficacy of the device as there are a wide range of number of LEDs and power output devices cleared under device code OHS. Scientific and Performance Data i.e. bench

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testing and safety testing included in this submission shows the Elevare Plus device is substantially equivalent to the predicate and reference devices. Based on technology, similar design, wavelength parameters and treatment regime these differences between the Elevare Plus device and predicate device does not adversely affect the safety or efficacv of the device

7. Performance Data/Non-Clinical Testing:

The conclusions drawn from the nonclinical testing below demonstrate that the Elevare Plus device is substantially equivalent to the legally marketed devices identified in section 3.

SAFETY TESTING

The Elevare Plus device has been tested and conforms to international consensus standards:

ELECTRICAL SAFETY:

Recognition Number 19-4:

IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012 Medical Electrical Equipment Part . 1: General Requirements For Basic Safety And Essential Performance (Iec 60601-1.2005, Mod). (General II (ES/EMC))

EMC:

Recognition Number 19-8:

IEC 60601-1-2 Edition 4: 2014, Medical Electrical Equipment Part 1-2: General ● Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances- Requirements And Tests. (General II (ES/EMC))

BIOCOMPATIBILITY:

Recognition Number 2-156:

ISO 10993-1:2009/(R) 2013. Biological Evaluation Of Medical Devices -- Part 1: Evaluation ● And Testing Within A Risk Management Process. (Biocompatibility)

Recognition Number 2-153:

ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For ● In Vitro Cytotoxicity. (Biocompatibility)

Recognition Number: 2-174:

ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices Part ● 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)

ADDITIONAL SAFETY TESTING:

Recognition Number 12-249:

IEC 62471 First Edition 2006-07, Photobiological Safety Of Lamps And Lamp ● Systems. (Radiology)

Recognition Number 19-14:

IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment Part 1-11: General ● Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment

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The Elevare Plus device has been tested to ensure the device meets specifications:

PERFORMANCE TESTING:

. Software Validation Testing

The Elevare Plus device's software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."

. Skin Temperature Testing

Two devices were tested for heat output, with the treatment surface contacting the skin. Temperatures were recorded every 1 minute, up to 30 minutes, using a calibrated digital temperature sensor, around areas of the face. The test was performed under nominal use conditions and the device used in accordance with the recommended use approach (continuous movement during treatment). The test results concluded that the Elevare Plus device was within specification of 41+/- 2 ºC and did not elevate skin temperature above 43ºC.

. Wavelength/Power Output Testing

The Elevare Plus device was tested for the following optical and electrical characteristics to ensure product meets specifications:

1. Radiant Flux (Output energy), W
1. Output energy Spectral distribution, W/nm

PREDICATE COMPARISON TESTING:

Evaluation testing was done on several FDA cleared devices that have the same indications for use i.e. treating wrinkles on the face.

The devices were evaluated for total power output and specific irradiance levels (Spectral Flux was measured) for each of the stated wavelengths cited in the respective device's 510k Summary.

The conclusion from this testing demonstrated that the Elevare Plus device is substantially equivalent to other legally marketed devices.

8. Substantial Equivalence Conclusion

After an analysis of the safety, indications, intended uses, performance, design materials, power output, technological properties, treatment areas, treatment regimes and methods of operation, the manufacturer believes that no significant differences exist between the device and the predicate and reference devices and no new issues arise for safety and effectiveness. Therefore substantial equivalency is hereby requested.

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.