(173 days)
Not Found
No
The summary describes a laser system for wrinkle treatment and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the treatment of periorbital wrinkles, directly addressing a medical condition.
No
The device is indicated for the "treatment of periorbital wrinkles (crow's feet)," not for diagnosis.
No
The device description explicitly states it is a "semiconductor diode laser system," which is a hardware component, not 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 "treatment of periorbital wrinkles (crow's feet)". This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a laser system that delivers infrared light. This is a physical treatment modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVDs are used to perform tests on samples taken from the human body to provide information about a person's health. The Tria FANp is a device that directly interacts with the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The FANp is an over-the-counter device indicated for the treatment of periorbital wrinkles (crow's feet).
Product codes
ONG
Device Description
The Tria FANp is a semiconductor diode laser system that delivers infrared light at a wavelength of 1450 nm ± 50 nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital (crow's feet)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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
Animal: A GLP compliant histology study was conducted. Hairless guinea pigs were treated with the Tria FANp and tissue sampling occurred immediately, 5 days, and 14 days post-treatment. The tissue response was found to be equivalent to the predicate nonablative fractional device.
Clinical: A 45-subject, prospective, open-label safety and effectiveness study was conducted to evaluate the Tria FANp for the treatment of periorbital wrinkles. The Tria FANp was found to be as safe and effective as the predicate non-ablative fractional device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 30, 2014
Tria Beauty Incorporated % Mr. Johnathan Kahan Hogan Lovells US LLP 555 Thirteenth Street, North West Washington, District of Columbia 20004
Re: K141868 Trade/Device Name: Tria FANp 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: ONG Dated: November 12, 2014 Received: November 12, 2014
Dear Mr. Kahan:
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
1
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 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,
David Krause -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
2
Indications for Use
510(k) Number (if known) K141868
Device Name Tria Fanp
Indications for Use (Describe)
The FANp is an over-the-counter device indicated for the treatment of periorbital wrinkles (crow's feet).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
Tria Beauty's Tria FANp
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Tria Beauty, Inc. 4160 Dublin Blvd. Ste 200 Dublin, CA 94568 Phone: 925-452-2500 Facsimile: 925-452-2595 Contact Person: Tobin Island, Ph.D. Date Prepared: June 30, 2014
Name of Device and Name/Address of Sponsor
Tria FANp Tria Beauty, Inc. 4160 Dublin Blvd, Ste 200 Dublin, CA 94568
Common or Usual Name
Diode Laser
Classification Name
Laser Instrument, Surgical, Powered Regulation Number: 21 CFR§878.4810 Product Code: ONG
Predicate Devices
Tria Beauty, Inc., Tria FAN System (K130459)
Intended Use / Indications for Use
Tria FANp is an over-the-counter device indicated for the treatment of periorbital wrinkles (crow's feet).
Technological Characteristics
The Tria FANp is a semiconductor diode laser system that delivers infrared light at a wavelength of 1450 nm ± 50 nm.
Performance Data
Performance data was submitted with this 510(k) notification to support the determination of substantial equivalence for the Tria FANp relative to its predicate device.
4
Performance Testing (Non-Clinical):
Performance testing was conducted to demonstrate that the Tria FANp performs according to specifications and functions as intended.
Animal:
A GLP compliant histology study was conducted. Hairless guinea pigs were treated with the Tria FANp and tissue sampling occurred immediately, 5 days, and 14 days post-treatment. The tissue response was found to be equivalent to the predicate nonablative fractional device.
Clinical:
A 45-subject, prospective, open-label safety and effectiveness study was conducted to evaluate the Tria FANp for the treatment of periorbital wrinkles. The Tria FANp was found to be as safe and effective as the predicate non-ablative fractional device.
Substantial Equivalence
The Tria FANp has the same intended use and indication, the same principles of operation, and similar technological characteristics as its predicate device. The minor technological differences between the Tria FANp and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Tria FANp is as safe and effective as the predicate device. Thus, the Tria FANp is substantially equivalent.