The Trinity Plus Wrinkle Reducer is an over-the-counter hand-held for reduction of full-face fine lines and wrinkles, and increase in local circulation within the perioral region.

Device Description

The Trinity Plus Wrinkle Reducer (hereinafter referred to as "TWR Plus") comprises the TWR Plus main body, a TWR Plus light attachment head, a charging cradle, and a wall-mount power adaptor. The device and all its associated components are reusable and provided non-sterile.

The TWR Plus is a hand-held phototherapy device that emits Red and Infrared (IR) light energy in the 605, 630, 645, 660 and 855 nanometer wavelengths via a light attachment head. The light attachment head comprises (34) Light Emitting Diodes (LED's) which are the source of the light energy. The Red and IR light energy is used in the treatment of fine lines and wrinkles around eyes, mouth, and forehead and promotes local blood circulation.

The subject device includes three indicator LED's, one internal speaker and one vibration motor. These features provide visual, audible, and haptic feedback to the user during normal operation. The light attachment head includes a proximity sensor to detect when device is pressed onto the skin.

The subject device is turned on and turned off via a dedicated ON/OFF button. Once the subject device is ON, the user follows the provided Instructions for Use to start the treatment. The ON/OFF button also serves as a multi-function User Interface (UI) button by allowing the User to control other functions while the subject device is in Standby, Treating, Charging or Sleep modes. A long press of approximately one second on the ON/OFF button can stop treatment at any time.

Upon power up, the three indicator lights turn on and an ascending audible beep is emitted notifying the user that the device is ON. Once the device is ON, the light therapy LEDs are set to a visible, but significantly dimmed non-treatment state. As the device is placed in direct contact with the skin, the proximity sensor will turn the light therapy LEDs on to start the treatment. While in treatment, if the device is moved away from the skin, the device emits three beeps, and the LEDs revert to the significantly dimmed non-treatment state. The device also emits two beeps to inform the user when a treatment interval is complete and that it is time to treat another section of skin. The device automatically Shuts OFF after 24 minutes of use to indicate the treatment is complete.

The device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle is powered by a pre-approved wall-mount power supply. The light energy output power is zero watts while the device is in the charging cradle or when turned off. All charging circuitry is contained within the handheld unit itself.

The housings of TWR Plus main body, the light attachment head and the charging cradle are made from injection molded thermoplastic resins. The light attachment head, which is intended to come in contact with the skin, is made from a biocompatible polymer material. The TWR Plus, including the light attachment head, measures 5.4" H x 2.6" W x 1.7" D and weighs 7.8 oz. The charging cradle measures 2.3" H x 3.0" W x 2.7" D and weighs 7.30 oz.

The TWR Plus uses Bluetooth Low Energy (BLE) wireless technology to pair to and connect with compatible devices capable of running the NuFACE® App. The NuFACE® App allows the user to select and run pre-programmed treatment profiles stored in the device.

Device component list:

1 x TWR Plus Main Body
1 x TWR Plus Light Attachment Head
1 x Wireless Charging Cradle
1 x Pre-approved wall-mount power adaptor

AI/ML Overview

The provided text is a 510(k) Summary for the NuFACE® Trinity Plus Wrinkle Reducer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving the detailed performance metrics through rigorous clinical studies often associated with novel or high-risk devices. As such, the information typically requested in your prompt (e.g., acceptance criteria for clinical performance, sample sizes for test sets, expert qualifications, MRMC studies, specific ground truth types) is largely absent because it was not required for this type of submission.

Here's an analysis based on the provided document:

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

The document does not provide a specific table of acceptance criteria for clinical performance (e.g., specific percentage reduction of wrinkles, or circulation increase metrics) nor does it report device performance in those terms. Instead, the "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device is as safe and effective as a predicate device.

The reported "performance" is concluded through:

Biocompatibility Evaluation: The materials (ABS Thermoplastic and a Polymer for the lens) were deemed biocompatible for surface device, intact skin, limited (<24h) duration contact. Specific performance metrics are not given, only the conclusion of biocompatibility.
Safety, Performance and Bench Testing (Optical Safety, Electrical Safety, EMC, Wireless Coexistence): The conclusion is that the device "meets and complies with the safety and performance of the applicable standards and bench testing requirements." No specific quantitative results or acceptance thresholds are provided in this summary.
Software Verification and Validation: Concluded that the device "meets and complies with the applicable software requirements specifications." No detailed performance metrics are given.

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

Test Set Sample Size: No information on a "test set" in the context of clinical performance is provided because no clinical testing was performed or deemed necessary to support substantial equivalence.
Data Provenance: Not applicable as no clinical data for performance assessment (wrinkle reduction/circulation increase) was collected for this submission. The non-clinical testing data provenance is not specified (e.g., in-house labs, certified external labs).

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)

Not applicable. No clinical test set with human "ground truth" establishment was performed or reported for this 510(k) submission.

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

Not applicable. No clinical test set requiring adjudication was performed.

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

Not applicable. This device is a direct-to-consumer medical device for wrinkle reduction and local circulation increase, not an AI-assisted diagnostic or interpretative system that would involve human "readers" or MRMC studies.

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

This concept is not relevant to the device described. The device is a physical light therapy device, not an algorithm. Its performance is measured by its physical output and safety, and by comparing its technological characteristics to a predicate device, not by an algorithm's classification performance.

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

Not applicable for clinical performance. For the non-clinical tests (biocompatibility, electrical/optical safety, EMC, software), the "ground truth" is adherence to established industry standards and internal design specifications.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary of Device Performance and 510(k) Claims:

The 510(k) submission for the Trinity Plus Wrinkle Reducer relies on demonstrating substantial equivalence to existing predicate devices (NuFACE® Trinity Wrinkle Remover K120560 and reVive Perioral LED Light Therapy System K172662). This regulatory pathway often does not require new clinical studies if the technological characteristics and indications for use are similar to a predicate device that has already established its safety and effectiveness.

The "study that proves the device meets the acceptance criteria" in this context is the compilation of non-clinical performance data and the comparison to predicate devices:

Biocompatibility Evaluation: Concluded the materials are biocompatible based on industry standards and prior use in other FDA-cleared devices.
Safety, Performance and Bench Testing (Optical Safety, Electrical Safety, EMC, Wireless Coexistence): Concluded compliance with applicable standards.
Software Verification and Validation: Concluded compliance with software requirements.

The core argument for acceptance is presented in Section 8, "Overall Conclusion":
"The documentation and test results provided in this submission and comparison of intended use, principle of operation, performance data, design and the overall technological characteristics, demonstrate that the NuFACE® Trinity Plus Wrinkle Reducer device is substantially equivalent to the predicate device."

Therefore, the "acceptance criteria" here relate to meeting the necessary non-clinical standards and successfully demonstrating equivalence to a predicate, rather than achieving specific performance thresholds in a de novo clinical trial.

Summary

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April 2, 2022

Carol Cole Company dba NuFACE % Bob Duffy President Bob Duffy Associates, Inc. 16405 Summer Sage Rd. Poway, California 92064

Re: K212947

Trade/Device Name: Trinity Plus Wrinkle Reducer 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: [NOTE: Use date of most recent supplement] Received: September 15, 2021

Dear Bob 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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

Enclosure

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Indications for Use

510(k) Number (if known) K212947

Device Name Trinity Plus Wrinkle Reducer

Indications for Use (Describe)

The Trinity Plus Wrinkle Reducer is an over-the-counter hand-held for reduction of full-face fine lines and wrinkles, and increase in local 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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K212947

510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements established by 21 CFR 807.92.

1. Submitter/Owner

Carol Cole Company dba NūFACE 1325 Sycamore Ave, Suite A Vista, CA 92081 (USA)

Contact Person:	Tera Peterson
	Chief Executive Officer
	Phone: (760) 509-1187
	Email: tpeterson@myNuFACE.com

Date Prepared: March 30, 2022

2. Subject Device

Device Trade / Proprietary Name:	Trinity Plus Wrinkle Reducer
Device Common or Usual Name:	Light based over the counter wrinkle reduction device
Regulation Number:	21 CFR 878.4810
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology
Product Code:	OHS
FDA Panel:	79 - General and Plastic Surgery
Class:	II

3. Predicate Devices

Legally marketed predicate devices to which the Carol Cole Company dba NūFACE is claiming substantial equivalence to:

510(k) Number	K120560	K172662
Manufacturer	Carol Cole Company dba NūFACE	LED Technologies, Inc
Trade Name	NūFACE® Trinity WrinkleRemover	reVive Perioral LED Light TherapySystem
Product Code	OHS	OHS, ILY
Regulation Number	21 CFR 878.4810
Classification Name	Laser Surgical Instrument for Use in General and Plastic Surgery and inDermatology
FDA Panel	79 - General and Plastic Surgery
Class	II

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4. Device Description

Device component list:

1 x TWR Plus Main Body
1 x TWR Plus Light Attachment Head
1 x Wireless Charging Cradle
1 x Pre-approved wall-mount power adaptor

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5. Indications for Use

The Trinity Plus Wrinkle Reducer is an over-the-counter hand-held device intended for the reduction of full-face fine lines and wrinkles, and increase in local circulation within the perioral region.

6. Device Comparison Table

Item	Subject Device	Predicate Device(K120560)	Predicate Device(K172662)
Type of EnergyOutput	IR and Red light	IR and Red light	IR and Red light
Energy Delivery	Electromagnetic energy isradiated via an array ofLEDs	Electromagnetic energy isradiated via an array ofLEDs	Electromagnetic energy isradiated via an array ofLEDs
Wavelength Range	605, 630, 645, 660 and 855nm	605, 630, 660 and 855 nm	605, 630, 660 and 880 nm
Energy OutputLevel	Fixed, not user adjustable	Fixed, not user adjustable	Fixed, not user adjustable
Energy PowerSource	Internal RechargeableBattery	Internal RechargeableBattery	Internal RechargeableBattery
Power Accessories	Device-specific chargingcradle	Device-specific chargingcradle	Universal USB chargercord
Charging Method	Wireless charging	Contact charging	Contact charging
Battery Type	Lithium-Ion	Nickel-Metal Hydride	Lithium-Ion
Power Supply Type	Pre-approved wall-mountPower Adaptor	Pre-approved wall-mountPower Adaptor	USB Power Supply
WirelessTechnology	Bluetooth® Low Energy(BLE)	None	None

The devices use the same type of red and infrared LED technology, and the proposed light-emitting device does not raise new types of questions regarding safety and efficacy for the proposed indications for use. Although there are differences between the proposed and predicate devices, performance testing discussed below supports that the proposed device can be used safely and effectively for the proposed indications for use.

7. Non-Clinical Performance Data

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7.1. Summary of Testing Performed

A program of design verification and validation testing and evaluation was conducted that includes the following:

Biocompatibility Evaluation
Safety, Performance and Bench Testing including EMC ●
Software Verification and Validation Testing ●

7.2. Conclusions from Biocompatibility Evaluation

A biocompatibility conclusions summary for the all patient-contacting materials is presented below.

Material	Where Used	Nature of body contact	Conclusion
ABSThermoplastic	Enclosures (housings) forthe subject device mainbody, the light attachmenthead and the charging cradleand wall-mount powersupply	Surface device, intactskin, limited (<24h)duration.	Biocompatible. Thismaterial is used in otherFDA-cleared devices.
Polymer	Lens of the light attachmenthead	Surface device, intactskin, limited (<24h)duration.	Biocompatible. Permanufacturer's Certificateof Compliance for ISO10993 Biocompatibilitytests.

7.3. Conclusions from Safety, Performance and Bench Testing

The safety and performance testing results for Optical Safety, Electrical Safety, EMC, Wireless Coexistence and bench testing concluded that the TWR Plus device meets and complies with the safety and performance of the applicable standards and bench testing requirements.

7.4. Conclusions from Software Verification and Validation

The software verification and validation results concluded that the TWR Plus device meets and complies with the applicable software requirements specifications.

7.5. Animal Testing

The substantial equivalence for the subject device will not be supported by animal testing. Therefore, no animal testing was conducted.

7.6. Clinical Testing

Clinical testing was not considered to be needed in this premarket notification in order to support substantial equivalence.

8. Overall Conclusion

The documentation and test results provided in this submission and comparison of intended use, principle of operation, performance data, design and the overall technological characteristics, demonstrate that the NuFACE® Trinity Plus Wrinkle Reducer device is substantially equivalent to 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.