Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties of the LED light and its application, with no mention of AI/ML algorithms, data processing, or learning capabilities.

Therapeutic

Yes.
The device is intended to treat wrinkles on the face, which is a therapeutic purpose.

Diagnostic

No
The device is described as an Over-the-Counter (OTC) device intended for treating wrinkles, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "battery powered, hand-held light emitting diode (LED) device" and lists hardware components like the handheld unit, batteries, power adapter, charging cord, charging cradle, and travel case. While software validation testing is mentioned, the core functionality and components are hardware-based.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "treating wrinkles on the face." This is a therapeutic or cosmetic application, not a diagnostic one.
Device Description: The device is a light-emitting device applied to the skin. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.), which is the core of an IVD.
Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples or providing diagnostic information.

IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The Elevare Plus is used for treatment, not diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

OHS

Device Description

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Face / Entire Face

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Electrical Safety: The Elevare Plus device has been tested and conforms to IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012.
EMC: The Elevare Plus device has been tested and conforms to IEC 60601-1-2 Edition 4: 2014.
Biocompatibility: The Elevare Plus device has been tested and conforms to ISO 10993-1:2009/(R) 2013, ISO 10993-5:2009/(R) 2014, and ISO 10993-10 Third Edition 2010-08-01.
Additional Safety Testing: The Elevare Plus device has been tested and conforms to IEC 62471 First Edition 2006-07 and IEC 60601-1-11 Edition 2.0 2015-01.
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 degrees Celsius and did not elevate skin temperature above 43 degrees Celsius.
Wavelength/Power Output Testing: The Elevare Plus device was tested for Radiant Flux (Output energy) and Output energy Spectral distribution.
Predicate Comparison Testing: Evaluation testing was done on several FDA cleared devices with the same indications for use. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K141181

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K120775, K120560

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

1

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

2

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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-DeWe
2424 Dempster Drive
Coralville, IA 52241
Tel.: 865-982-5552

Email: sue@fdalistingconsultants.com
On behalf of Sponsor: Omm Imports, Inc. d/b/a Zero Gravity
9737 NW 41st Street STE 234
Doral, 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)

4

4. Device Description:

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).

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	Elevare
Plus	NUVE for
Wrinkles	LightStim for
Wrinkles	Trinity Wrinkle
Remover
	Omm
Imports,
Inc. d/b/a
Zero
Gravity	LED
Technologies,
LLC	LED Intellectual	Carol Cole
Company
	K172909	K141181	K120775	K120560
	This
Submission	A Predicate
Device	A Reference
Device	A Reference
Device
Indications	The Elevare

is an Over-
the-Counter
(OTC) device
intended for
the use in
treating
wrinkles on
the face. | The Nüve for
Wrinkles is an
Over-the-Counter
(OTC) device
intended for the
use in treating
full-face
wrinkles. | The Lightstim for
Wrinkles is an
OTC hand-held
device intended
for the use in the
treatment of full-
face wrinkles | The Trinity
Wrinkle Remover
is an OTC hand-
held device
intended for use
in the treatment
of full-face
wrinkles |
| 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 Contact
Sensor, Fan,
Temperatur
e Sensor, in-
activity
timer | Unknown | Unknown | unknown |
| Irradiance source | LED | LED | LED | LED |
| Visible light LEDs | Yes | Yes | Yes | Yes |
| LED
Array/Arrangeme
nt | 25 LEDs
Over 17 cm2 | 60 LEDs. Over
30cm2 | 72 LEDs. Over
40cm2 | 36 LEDs. Over
1.25"D |
| Energy Level | 65 mW total | 65 mW total | 65 mW total | Unknown |
| (mW/cm2) | (+/- 5 mW) | (in 510k
Summary) | (in 510k
Summary) | |
| Power Supply | 2 Li-Ion
rechargeable
batteries | 28v DC power
supply | 9-volt DC power
transformer | 4 rechargeable
batteries |
| Treatment Time | 3 minutes
daily, 5 days
per week for
8 weeks | 3 minutes daily, 5
days per week
for 8 weeks | 3 minutes daily, 5
days per week for
8 weeks | 3 minutes each
area, 21 minutes
total minimum 5
days per week for
8 weeks |
| Target Population | Individuals
with
wrinkles on
the face | Individuals with
wrinkles on the
face | Individuals with
wrinkles on the
face | Individuals with
wrinkles on the
face |
| Location for Use | OTC | OTC | OTC | OTC |

5

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

6

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

7

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.