(256 days)
No
The description focuses on light emission at fixed wavelengths and intensity, with simple audio cues for user guidance. There is no mention of data processing, learning, or adaptive behavior characteristic of AI/ML.
Yes
The device is described as "intended for the use in the treatment of full-face wrinkles," which indicates a therapeutic purpose.
No
The device is described as a "Wrinkle Remover" intended for "treatment of full-face wrinkles" and emits light energy to "reduce fine lines and wrinkles." There is no mention of it diagnosing any conditions or collecting diagnostic information.
No
The device description clearly details physical hardware components including LEDs, batteries, an outer case, a charging cradle, and a power supply. It is a hand-held device that emits light energy.
Based on the provided information, the Trinity Wrinkle Remover is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "treatment of full-face wrinkles." This is a therapeutic or cosmetic purpose, not a diagnostic one.
- Mechanism of Action: The device uses light energy (red and IR) to reduce wrinkles. This is a physical interaction with the body, not an analysis of biological samples.
- Lack of Diagnostic Activity: There is no mention of the device analyzing blood, tissue, or any other biological sample to provide diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Trinity Wrinkle Remover does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OHS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
full-face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter
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)
Not Found
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.
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.
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
§ 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 contains 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 in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it. The logos are placed side by side.
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
1
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
2
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
3
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
4
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:
-
- 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.
-
- 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.
5
TECHNOLOGICAL CHARACTERISTICS
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.
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.