(199 days)
No
The description details a phototherapy device with basic sensor feedback and Bluetooth connectivity for pre-programmed treatments. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for the reduction of fine lines and wrinkles and to increase local circulation, which are therapeutic effects.
No
The device is described as a phototherapy device for the reduction of fine lines and wrinkles and increase in local circulation; it does not mention any diagnostic capabilities or functions.
No
The device description clearly outlines multiple hardware components including a main body, light attachment head, charging cradle, power adaptor, LEDs, proximity sensor, speaker, vibration motor, and battery. While it utilizes software for control and interaction with an app, it is fundamentally a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reduction of fine lines and wrinkles and increasing local circulation. This is a therapeutic/cosmetic application, not a diagnostic one.
- Device Description: The device is a phototherapy device that emits light energy. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, diagnose, monitor, or predict any disease or condition by examining samples from the human body.
IVD devices are specifically designed to perform tests on biological samples to provide information about a person's health status. This device's function is entirely external and focused on delivering light therapy to the skin.
N/A
Intended Use / 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.
Product codes
OHS
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
full-face, perioral region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
Biocompatibility conclusions:
- Material: ABS Thermoplastic, Where Used: Enclosures (housings) for the subject device main body, the light attachment head and the charging cradle and wall-mount power supply, Nature of body contact: Surface device, intact skin, limited (
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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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3
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 surgery |
| and 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 Wrinkle | |
| Remover | reVive Perioral LED Light Therapy | |
| System | ||
| Product Code | OHS | OHS, ILY |
| Regulation Number | 21 CFR 878.4810 | |
| Classification Name | Laser Surgical Instrument for Use in General and Plastic Surgery and in | |
| Dermatology | ||
| FDA Panel | 79 - General and Plastic Surgery | |
| Class | II |
4
4. 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
5
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 Energy
Output | IR and Red light | IR and Red light | IR and Red light |
| Energy Delivery | Electromagnetic energy is
radiated via an array of
LEDs | Electromagnetic energy is
radiated via an array of
LEDs | Electromagnetic energy is
radiated via an array of
LEDs |
| Wavelength Range | 605, 630, 645, 660 and 855
nm | 605, 630, 660 and 855 nm | 605, 630, 660 and 880 nm |
| Energy Output
Level | Fixed, not user adjustable | Fixed, not user adjustable | Fixed, not user adjustable |
| Energy Power
Source | Internal Rechargeable
Battery | Internal Rechargeable
Battery | Internal Rechargeable
Battery |
| Power Accessories | Device-specific charging
cradle | Device-specific charging
cradle | Universal USB charger
cord |
| Charging Method | Wireless charging | Contact charging | Contact charging |
| Battery Type | Lithium-Ion | Nickel-Metal Hydride | Lithium-Ion |
| Power Supply Type | Pre-approved wall-mount
Power Adaptor | Pre-approved wall-mount
Power Adaptor | USB Power Supply |
| Wireless
Technology | 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
6
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 |
|---|---|---|---|
| ABS | |||
| Thermoplastic | Enclosures (housings) for | ||
| the subject device main | |||
| body, the light attachment | |||
| head and the charging cradle | |||
| and wall-mount power | |||
| supply | Surface device, intact | ||
| skin, limited ( |