(333 days)
Not Found
No
The device description and intended use focus on light therapy and do not mention any AI/ML components or functionalities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device's description explicitly states it is intended to "treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris," and it "uses LEDs (light emitting diodes) to produce therapeutic blue light." This indicates a therapeutic intended use.
No
Explanation: The device is indicated to "treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris," which describes a therapeutic purpose, not a diagnostic one. There is no mention of identifying, detecting, or measuring a medical condition.
No
The device description explicitly states it is a "handheld, electrically powered device that uses LEDs," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris." This describes a therapeutic treatment applied directly to the body, not a test performed on a sample taken from the body.
- Device Description: The device uses LEDs to produce blue light for therapeutic purposes. This is a physical treatment method, not a diagnostic test.
- 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 samples
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests on samples taken from the human body to provide information about a person's health status. This device is a therapeutic device that applies light to the skin for treatment.
N/A
Intended Use / Indications for Use
The ATS-1 OTC is generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris. It is intended for over-the-counter use.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The ATS-1 OTC is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
TRIA Beauty claims that the ATS-1 OTC performance data is substantially equivalent to the predicate devices, including and especially the company's previously cleared ATS-1 (K060567). Performance and consumer usability data is submitted with this 510(k) notification.
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.
K060567, K060653, K043377, K080591
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.
Not Found
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
KC090312
510(k) SUMMARY
ATS-1 OTC
JAN - 5 2010
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
TRIA Beauty, Inc. 5880 W. Las Positas Blvd., Suite 52 Pleasanton, CA 94588-8552 Phone: 925-701-2549 Facsimile: 925-701-2598 Contact Person: Tobin C. Island, Ph.D. Date Prepared: February 5, 2009
Name of Device and Name/Address of Sponsor
TRIA Acne Treatment System (ATS-1 OTC) TRIA Beauty, Inc. 5880 W. Las Positas Blvd., Suite 52 -Pleasanton, CA 94588-8552
Common or Usual Name
Light Emitting Diode Therapy System
Classification Name
Laser Instrument, Surgical, Powered Regulation Number: 21 C.F.R.§ 878.4810 Product Code: GEX
Predicate Devices
ATS-1 by TRIA Beauty, Inc. (formerly SpectraGenics, Inc.) (K060567) ThermaClear by Therative, Inc. (K060653) Zeno by Tyrell, Inc. (K043377) Tanda by Pharos Life Corporation (K080591)
1
Intended Use / Indications for Use
- The ATS-1 OTC is generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris. It is intended for over-the-counter use.
Technological Characteristics
The ATS-1 OTC is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.
Performance Data
न्न
TRIA Beauty claims that the ATS-1 OTC performance data is substantially equivalent to the predicate devices, including and especially the company's previously cleared ATS-1 (K060567). Performance and consumer usability data is submitted with this 510(k) notification.
Substantial Equivalence
The ATS-1 OTC has substantially the same intended use, indications for use, technological parameters, and mechanism of action as the predicate device(s). Furthermore, the performance and consumer usability data demonstrates that any technological differences or changes in labeling do not raise new questions of safety or efficacy or alter the device's intended therapeutic effect in comparison to the predicates. Therefore, the ATS-1 OTC is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the 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 a stylized image of an eagle or bird with outstretched wings, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN - 5 2010
TRIA Beauty, Inc. % Hogan and Hartson LLP Mr. Jonathan S. Kahan Columbia Square 555 13th Street, N.W. Washington, District of Columbia 20004
Re: K090312
Trade/Device Name: TRIA Acne Treatment System (ATS-1 OTC) 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: GEX Dated: December 09, 2009 Received: December 09, 2009
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
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Page 2 – Mr. Jonathan S. Kahan
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 (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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: ATS-1 OTC
Indications for Use:
The TRIA Beauty ATS-1 OTC is generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q
Division Sign-Off) Division Sign-Off)
Division of Surgical ( rthopedic,
Division of Surgical ( res ിഴിടിന്ന് of Suid Restorative Dev 510(k) Number -
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