The Nüve for Wrinkles is an over-the-counter hand-held light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and fine lines. 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 adiustments required.

The Nuve for Wrinkles system components include the handheld unit containing the LED module , power supply, goggles, 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 document is a 510(k) summary for the NUVE FOR WRINKLES device. It outlines the device description, indications for use, comparison to predicate devices, and performance testing. However, it does not contain specific acceptance criteria for performance metrics (such as accuracy, sensitivity, specificity, etc.) related to its effectiveness in treating wrinkles, nor does it detail a clinical study with a control group or comparative effectiveness against human readers.

The performance testing section focuses on safety, functional performance, software validation, and usability, rather than clinical efficacy measured against specific criteria.

Therefore, many of the requested information points, especially those pertaining to clinical efficacy, ground truth, expert adjudication, and MRMC studies, cannot be extracted from this document as they are not present.

Here's the information that can be extracted, and where applicable, a note stating that the information is not available in the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated for clinical efficacy)	Reported Device Performance (Focus on safety, usability, and functionality)
Safe operation (implicitly, from standards compliance)	Conforms to IEC 60601-1, IEC 60601-1-2, ISO 10993-10, IEC 60825-1 (Safety and electrical standards)
Functional performance (not specified beyond "performs as intended")	Not explicitly quantified; "system performs as intended" is stated.
Software validation (implicitly, from guidance compliance)	Tested and validated in accordance with FDA guidance for software in medical devices.
User ability to demonstrate light sensitivity test	100% of participants were able to demonstrate the light sensitivity test.
User ability to use the device successfully	100% of participants were able to use the device successfully.
Substantial equivalence to predicate devices (regarding indications, output, wavelengths, treatment duration, and regimen)	Same intended use, similar output (65 mW/cm²), same number of wavelengths (4 between 605 nm - 880 nm), same treatment duration (180 seconds), same treatment regimen (5 days/week for 8 weeks) as predicate devices.

Study Details

Sample size used for the test set and the data provenance:
- A "Usability Study" was conducted with 38 participants.
- The document does not specify the provenance of these participants (e.g., country of origin). It's a usability study, not a clinical efficacy study with data related to wrinkle reduction.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a usability study demonstrating the ability of participants to use the device and demonstrate a light sensitivity test, not a study establishing ground truth for clinical efficacy of wrinkle reduction.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. The usability study evaluated user interaction, not clinical outcomes requiring adjudication.
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, an MRMC comparative effectiveness study was not done. This device is a light-emitting diode (LED) device for wrinkle reduction, not an AI-assisted diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical device, not an algorithm. Its performance is inherent to its physical operation and user interaction, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the usability study, the "ground truth" was whether participants could successfully perform a light sensitivity test and use the device. This is a direct observation of user interaction, not a medical "ground truth" like pathology or expert consensus on disease.
- For efficacy, the document does not present clinical trial data with defined ground truth for wrinkle reduction. The claim of effectiveness is based on substantial equivalence to predicate devices which presumably had such data in their original submissions.
The sample size for the training set:
- Not applicable. This document is for a hardware device, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable for the reason above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 31, 2015

LED Technologies, LLC % Ms. Susan Anthoney-DeWet Aegis Regulatory Incorporated 2424 Dempster Drive Coralville, Iowa 52241

Re: K141181

Trade/Device Name: NUVE FOR WRINKLES 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 2, 2015 Received: March 4, 2015

Dear Ms. 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 (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

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) K141181

Device Name NUVE FOR WRINKLES

Indications for Use (Describe)

The Nive for Wrinkles is an Over-the-Counter (OTC) device intended for the use in treating full-face wrinkles.

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

K 141181

This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR § 878.4810. Submission Date: April 1. 2014

Submitter Information: AEGIS Regulatory, Inc. - Susan Anthoney-DeWet 2424 Dempster Drive Coralville, IA 52241 Tel.: 865-982-5552 Email: sue@fdalistingconsultants.com

For Specifications Developer: LED Technologies

Attn: Ron Ferguson 133 County Road 17 Elizabeth, CO 80107 Tel.: 303-646-0543 x 155 Email: rferguson@ledtechnologies.com

2. General Information

2.1 Classification Name: Light Based Over-The-Counter Wrinkle Reduction Device 2.2 Common/Usual Name: Red Light Therapy Device 2.3 Proprietary Names: NÜVE for Wrinkles 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. Device Description:

The Nuve for Wrinkles system components include the handheld unit containing the LED module , power supply, goggles, and travel case.

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4. Indications / Intended Use:

The Nüve for Wrinkles is an Over-the-Counter (OTC) device intended for the use in treating full-face wrinkles.

Rx or OTC:

The Nüve for Wrinkles is an Over the Counter (OTC) device. The labeling, instructions, and User Operations (21 CFR § 801.60 and 61), are designed for layman understanding and use. The predicate devices are OTC.

5. Predicate Devices:

This device is substantially equivalent to the following predicates, which are currently in safe and effective commerce under product code OHS:

K120775 - LightStim for Wrinkles (LED Intellectual)
K120560- Trinity Wrinkle Remover (Carol Cole Company)
K101382-Dpl NUVE (LED Technologies, LLC)

Device	NUVE forWrinklesLEDTechnologies,LLCK141181	LightStim forWrinklesLED IntellectualK120775	Trinity WrinkleRemoverCarol ColeCompanyK120560	Dpl NUVELEDTechnologies, LLCK101382
	This Submission	A Predicate Device	A Predicate Device	A PredicateDevice
Indications	The dpl- Nüve forWrinkles is anOver-the-Counter(OTC) deviceintended for theuse in treating full-face wrinkles.	The Lightstim forWrinkles is an OTChand-held deviceintended for theuse in thetreatment of full-face wrinkles	The Trinity WrinkleRemover is anOTC hand-helddevice intended foruse in thetreatment of full-face wrinkles	The Dpl NUVEis intended toemit energy inthe red andinfrared regionof thespectrum foruse indermatologyfor thetreatment ofperiorbitalwrinkles.
Anatomical Sites	Entire Face	Entire Face	Entire Face	Periorbital
Handheld	Yes	Yes	Yes	Yes
Wavelengths	605,630,660,880nm	605,630,660,855nm	605,628,642,850nm	625, 830nm
Modes	On/Off	On/Off	On/Off	On/Off

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Irradiance source	LED	LED	LED	LED
Visible light LEDs	Yes	Yes	Yes	Yes
LEDArray/Arrangement	60 LEDs. Over30cm2	72 LEDs. Over40cm2	36 LEDs. Over1.25"D	120 LEDs over30 cm²
Energy Level	65 mW total	65 mW total	Unknown	55 mW/cm2
Power Supply	28v DC powersupply	9-volt DC powertransformer	4 rechargeablebatteries	28v DC powersupply
Treatment Time	3 minutes daily, 5days per week for8 weeks	3 minutes daily, 5days per week for 8weeks	3 minutes eacharea, 21 minutestotal minimum 5days per week for 8weeks	20 minutesevery otherday, switchingheads
Target Population	Individuals withwrinkles on theface	Individuals withwrinkles on theface	Individuals withwrinkles on theface	Individualswith periorbitallines andwrinkles.
Location for Use	OTC	OTC	OTC	OTC

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

Has the same intended use as the predicate devices (i.e., treatment of full-face wrinkles;
Has the similar output (i.e., 65 mW/cm2 ) as the predicate devices;
Utilizes the same number of wavelengths (i.e., 4 wavelengths between 605 nm- 880 nm) as the predicate devices:
Utilizes the same treatment duration (i.e., 180 seconds) as the predicate devices;
Utilizes the same treatment regimen of five days a week for eight weeks.

The NUVE for Wrinkles device 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 605nm 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. The devices are handheld, and intended to be placed directly on the skin. They are manufactured out of similar materials. Based upon comparison to the predicate devices, the NUVE for Wrinkles device has the same intended uses, with similar technological characteristics as the predicate devices. The system performs as intended and does not raise any new safety or effectiveness issues.

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6. Performance Testing and Standards:

Testing of the Nuve for Wrinkles included functional performance testing, software validation testing and user safety testing.

Safety and functionality testing demonstrates that the Nuve for Wrinkles conforms to various international consensus standards:

IEC 60601-1: (2006): Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance.

IEC 60601-1-2: (2007): Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Compatibility IEC 60825-1: (2007)

ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity

Safety Of Laser Products - Part 1: Equipment Classification, And Requirements

The Nuve for Wrinkles 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 38 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 as safe, as effective, and performs as well as the legally marketed devices.

7. Statement of Safety and Effectiveness:

The information in this 510(k) submission was used to support the safety and effectiveness of this device with respect to its cited predicates.

8. Substantial Equivalence Discussion

After analysis of safety, indications, intended uses, dose rates, performance, features, design materials, power output, technological properties, treatment areas, treatment regimes and methods of operation, the manufacturer asserts that no significant differences exist between the applicant device and predicates listed in the predicate chart, 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.