The Trinity Wrinkle Remover is an over-the-counter hand-held device for the use in the treatment of full-face wrinkles. It emits energy in the red and IR regions of the spectrum to reduce fine lines and wrinkles. The Subject device emits light energy at near identical levels as the Predicate device at the 605nm, 630nm, 660nm and 855nm wavelengths. The Subject device measured output spectral characteristics are identical to those of the Predicate device.

The device measures 3" W x 5.25" L x 1.25" D. Its outer case is injection molded of thermoplastic resin. The detachable Treatment Head comprises (36) Light Emitting Diodes (LED's) which emit light at the 605nm. 630nm. 660nm and 855nm wavelengths. The device is powered by 4 rechargeable batteries. The Trinity Wrinkle Remover comes with a Charging Cradle, which measures 3.25" W x 4" L x 3.25" D, to charge the internal batteries when not in use. The Charging Cradle is powered by d.c. power from a pre-approved wall-mount Power Supply provided with the device. All charging circuitry is contained within the handheld unit itself.

The Trinity Wrinkle Remover Treatment Head is designed for optimal contact with the face. The device continually pulses the LEDs output, and provides a fixed output intensity level. The device does not allow the output level to be changed. The '+' and '-' keys on the handle (main body) are not active when the Trinity Wrinkle Remover treatment Attachment is attached to the handle.

An ascending sequence of three audible beeps informs the User the device is ready for use. When the user turns off the device, a descending audible tone is emitted.

To promote proper use, a single audio beep every three minutes informs the user to relocate the device to treat a new location on the skin.

AI/ML Overview

This query pertains to a 510(k) summary for the Trinity Wrinkle Remover, which is a medical device for reducing full-face wrinkles. The 510(k) summary focuses primarily on establishing substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria or extensive clinical study results as one might find in a PMA or a more comprehensive clinical trial report.

Based on the provided text, the device is an over-the-counter hand-held device intended for the treatment of full-face wrinkles. The substantiation for its effectiveness and safety, and thus its "acceptance criteria" from an FDA 510(k) perspective, is primarily based on its technological characteristics being substantially equivalent to legally marketed predicate devices.

Here's an attempt to answer your questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for wrinkle reduction or specific cosmetic outcomes. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is therefore inferred to be similar to the cleared predicate devices.

Acceptance Criterion	Reported Device Performance (Trinity Wrinkle Remover)
Intended Use	Over-the-counter hand-held device for the use in the treatment of full-face wrinkles.
Technological Characteristics	Emits energy in the red and IR regions of the spectrum (605nm, 630nm, 660nm, and 855nm wavelengths). Measured output spectral characteristics and near identical intensity levels to predicate device.
Safety Standards Compliance	Conforms to IEC 62471:2006 (Photobiological safety), IEC 60601-1-2 (Electromagnetic Compatibility), and IEC 60601-1 (Electrical Safety).
Substantial Equivalence	Demonstrated substantial equivalence to "Light for Wrinkles" devices (K101190 and K120775) in terms of intended use, indications for use, and technological characteristics (emitting Red and IR energy at same wavelengths and similar intensities).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided 510(k) summary does not contain information about a specific clinical study involving a test set of subjects for evaluating wrinkle reduction effectiveness. The substantiation is based on comparison to predicate devices, and compliance with electrical and photobiological safety standards. Therefore, "sample size" for a clinical test set is not applicable to the information given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the 510(k) summary. Direct clinical evaluation with a ground truth established by experts is not detailed for this device within the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no mention of a specific clinical test set for wrinkle reduction evaluation.

5. 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

This type of study is not applicable to the "Trinity Wrinkle Remover," which is a light-based device for wrinkle reduction, not an AI-assisted diagnostic tool.

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

This refers to AI algorithm performance and is not applicable to this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the direct evaluation of wrinkle reduction effectiveness of the Trinity Wrinkle Remover, this information is not provided in the document. The "ground truth" for the 510(k) is the established safety and efficacy profile of the predicate devices.

8. The sample size for the training set

This refers to AI model training and is not applicable to this device.

9. How the ground truth for the training set was established

This refers to AI model training and is not applicable to this device.

Summary of Device and Study Information from the Document:

The provided document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. For the Trinity Wrinkle Remover, the primary "study" proving it meets acceptance criteria (i.e., is substantially equivalent and safe/effective for its intended use) is the comparison of its technological characteristics and intended use to those of previously cleared devices.

Predicate Devices: The device claims substantial equivalence to two "Light for Wrinkles" devices (K101190 and K120775) manufactured by LED Intellectual Properties, LLC.
Basis of Equivalence: The Trinity Wrinkle Remover has the same intended use (treatment of full-face wrinkles) and indications for use as the predicate devices. Technologically, it emits Red and IR energy at the same wavelengths (605nm, 630nm, 660nm, and 855nm) and similar intensities as the predicate device.
Safety Compliance: The device underwent testing and was found compliant with international standards for photobiological safety (IEC 62471:2006), electromagnetic compatibility (IEC 60601-1-2), and electrical safety (IEC 60601-1). This demonstrates its safety characteristics, rather than direct efficacy for wrinkle reduction.
Clinical Data: The 510(k) summary does not present clinical data from human subjects specifically demonstrating the efficacy of the Trinity Wrinkle Remover in reducing wrinkles. This is typical for 510(k) submissions where substantial equivalence to a predicate device with established efficacy is the primary pathway to market.

Summary

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January 19, 2022

Carol Cole Company Bob Duffy President 16405 Summer Sage Rd Poway, California 92064

Re: K120560

Trade/Device Name: Trinity Wrinkle Remover 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

Dear Bob Duffy:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 6th, 2012. Specifically, FDA is updating this SE Letter with a corrected 510(k) Summary, which includes the correct device characteristics, as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Purva Pandya, OHT4: Office of Surgical and Infection Control Devices, 240-402-9979, purva.pandva@fda.hhs.gov.

Sincerely,

Purva U. Pandya -S

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

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with three intertwined serpents around a staff.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Carol Cole Company % Bob Duffy Associates. Incorporated Mr. Bob Duffy President 16405 Summer Sage Road Poway, California 92064

November 6, 2012

Re: K120560

Trade/Device Name: Trinity Wrinkle Remover 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: October 28, 2012 Received: October 31, 2012

Dear Mr. Duffy:

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

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Page 2 - Mr. Bob Duffy

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

100560 510(k) Number (if known):

Device Name: Trinity Wrinkle Remover

Indications For Use:

The Trinity Wrinkle Remover is an over-the-counter hand-held device intended for the use in the treatment of full-face wrinkles.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X
(21 CFR 801 Subpart C)

(Division Sign-Off) (Division Sign-On), Orthopedic, Divisionative Devices

510(k) Number |
$$1120560$$
.

Carol Cole Company Trinity Wrinkle Remover 510(k) Submission Indications for Use - updated 11/2/2012

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510(k) Summary Trinity Wrinkle Remover

Prepared: December 15, 2021

CONTACT INFORMATION

Carol Cole Company 3146 Tiger Run Court; Suite 109 Carlsbad, California 92010

Phone: (760) 734-4545 Facsimile: (760) 734-4565 Email: tvaldez@mvnuface.com Contact Person: Tera Valdez, Vice President

DEVICE NAME

Trade Name: Trinity Wrinkle Remover Common Name: Light based over the counter wrinkle reduction device Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) Product Code: OHS

PREDICATE DEVICES

The Carol Cole Company is claiming substantial equivalence to the following devices:

1. Light for Wrinkles device, cleared under 510(k) K101190
- a. Device Proprietary Name: Light for Wrinkles
- b. Manufacturer: LED Intellectual Properties, LLC
- c. Product Code: OHS
- d. Indications for Use: The Light for Wrinkles is an over-the-counter handheld device intended for the use in the treatment of periorbital wrinkles.
1. Light For Wrinkles Device, Cleared under 510(k) K120775
- Device Proprietary Name: Light for Wrinkles a.
- b. Manufacturer: LED Intellectual Properties, LLC
- c. Product Code: OHS
- d. Indications for Use: The LightStim for Wrinkles is an Over-The Counter handheld device intended for the treatment of fullface wrinkles

The Trinity Wrinkle Remover is a new device design based on portions of the NuFACE® Trinity Facial Toning Device, which was cleared under K103472. The main body of the NuFACE® Trinity Facial Toning Device is used in conjunction with a new Treatment Head, that emits energy in the Red and IR region of the spectrum for reducing fine lines and wrinkles.

INDICATIONS FOR USE/INTENDED USE

The Trinity Wrinkle Remover is an over-the-counter hand-held device intended for the use in the treatment of full-face wrinkles.

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TECHNOLOGICAL CHARACTERISTICS

An ascending sequence of three audible beeps informs the User the device is ready for use. When the user turns off the device, a descending audible tone is emitted.

To promote proper use, a single audio beep every three minutes informs the user to relocate the device to treat a new location on the skin.

COMPLIANCE DATA

The Trinity Wrinkle Remover was tested and found to conform to International Standard IEC 62471:2006 for the Photobiological safety of lamps and lamp systems.

The Trinity Wrinkle Remover was also tested and found to be in compliance with IEC 60601-1-2 for Electromagnetic Compatibility (EMC). The Trinity Wrinkle Remover was evaluated and found to be in compliance with IEC 60601-1 for Electrical Safety.

SUBSTANTIAL EQUIVALENCE

The Trinity Wrinkle Remover has the same intended use and indications for use as the predicate devices. The Trinity Wrinkle Remover emits Red and IR energy at the same wavelengths and similar intensities as the predicate device.

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.