(113 days)
Not Found
No
The description focuses on the physical components and the principle of selective photothermolysis, with no mention of AI or ML.
Yes
The device is indicated for the treatment of various medical conditions such as benign cutaneous vascular lesions, benign pigmented lesions, and mild to moderate inflammatory Acne Vulgaris, which are therapeutic applications.
No
The provided text describes the Trios™ system as being indicated for "long term stable, or permanent, hair reduction; for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions and for the treatment of mild to moderate inflammatory Acne Vulgaris." These are all therapeutic or aesthetic treatments, not diagnostic purposes. The device description also focuses on the mechanism of "Selective Photothermolysis" for targeting cells, which is a treatment modality.
No
The device description clearly states it consists of hardware components such as a main console, operator control panel, and hand pieces, which generate light pulses. This is not a software-only device.
Based on the provided information, the Trios™ system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Trios™ System Function: The description clearly states that the Trios™ system uses pulsed light applied directly to the skin for aesthetic and therapeutic purposes (hair reduction, vascular lesions, pigmented lesions, acne). It does not involve analyzing samples taken from the body.
- Mechanism of Action: The principle of Selective Photothermolysis involves targeting light-sensitive cells in the skin, not analyzing biological markers in a sample.
Therefore, the Trios™ system falls under the category of a therapeutic or aesthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Trios™ system is indicated for long term stable, or permanent, hair reduction; for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions and for the treatment of mild to moderate inflammatory Acne Vulgaris.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
The use of TriosTM in aesthetic applications is based on the principle of Selective Photothermolysis. According to this principle, pulsed light parameters (wavelength, pulse duration and energy fluence) are chosen to selectively target light sensitive cells while minimizing damage to surrounding tissues.
TriosTM consists of the following major components:
- Main Console
- Operator Control Panel
- Three Hand Pieces
The main console contains the high voltage electronics, the control panel, monitoring modules and the cooling system.
The hand pieces house the mechanism which generates the light pulse. The hand piece is connected to the system console by an umbilicus cord containing electrical wiring. Light from a Xenon flash lamp, located in the hand piece, is directed through a long-pass optical filter and focused into a transparent light guide that is placed in contact with the skin.
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
Prescription 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)
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.
K072331, K050165, K060234, K030527
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
090399
Image /page/0/Picture/1 description: The image shows the word "VIORA" in a bold, sans-serif font. Above the word is a stylized graphic, resembling an infinity symbol with a curved line extending upwards from the left side. The text and graphic are black against a white background.
JUN 1 0 2009
510(k) Summary:
Trios™ System
Company Name: Viora Ltd.
Contact Person:
Danny Erez CEO
Telephone: +972-3-5622248 Fax: +972-3-5622247 E-mail: omri@vioramed.com
Authorized US Agent:
Josef Luzon - CEO Viora Inc. 30 Montgomery Street, Suite 660 Jersey City, NJ 07302
Telephone: (201) 332-4100 Fax: (201) 332-4200 E-mail: josef@vioramed.com
Date prepared: February 12, 2009
Trade Name:
TriosTM System
Classification name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Common/usual name: Trios IPL System
Product Code: - ONF
Regulation No.: 878.4810
Class: II
Panel identification: General and Plastic Surgery Panel.
ર-2
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090399
page 2 of 3
DR /
Predicate Device:
Radiancy Mistral Device from Radiancy (Israel) Ltd, Yavne, Israel, cleared under 510(k) # K072331;
IFL Professional System from Cyden Ltd, Swansea, Wales, UK, cleared under 510(k) # K050165; McCue Energist Ultra VPL Intense Pulse Light System from McCue PLC, Southhampton, UK, cleared under 510(k) # K060234 and
Lumenis Family of IPL Systems from Lumenis Inc, Santa Clara, CA, USA, cleared under 510(k) # K030527
Description of the device:
The use of Trios 1 in aesthetic applications is based on the principle of Selective Photothermolysis. According to this principle, pulsed light parameters (wavelength, pulse duration and energy fluence) are chosen to selectively target light sensitive cells while minimizing damage to surrounding tissues.
Trios The consists of the following major components:
- . Main Console
- Operator Control Panel .
- . Three Hand Pieces
The main console contains the high voltage electronics, the control panel, monitoring modules and the cooling system.
The hand pieces house the mechanism which generates the light pulse. The hand piece is connected to the system console by an umbilicus cord containing electrical wiring. Light from a Xenon flash lamp, located in the hand piece, is directed through a long-pass optical filter and focused into a transparent light guide that is placed in contact with the skin.
Indications for Use:
The Trios™ system is indicated for long term stable, or permanent, hair reduction; for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions and for the treatment of mild to moderate inflammatory Acne Vulgaris.
2
090399
Page 30f3
VIORA
Substantial Equivalence:
The Trios™ System has the same intended use and the same performance characteristics as the following predicate devices: Radiancy Mistral Device from Radiancy (Israel) Ltd, Yavne, Israel, cleared under 510(k) # K072331; IFL Professional System from Cyden Ltd, Swansea, Wales, UK, cleared under 510(k) # K050165; McCue Energist Ultra VPL Intense Pulse Light System from McCue PLC, Southhampton, UK, cleared under 510(k) # K060234 and Lumenis Family of IPL Systems from Lumenis Inc, Santa Clara, CA, USA, cleared under 510(k) # K030527. The Trios™ System is therefore substantially equivalent to those devices.
Conclusion -
The evaluation of the Trios™ System does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2009
VIORA Limited % Viora Incorporated Mr. Josef Luzon Chief Executive Officer 30 Montgomery Street, Suite 660 Jersey City, New Jersey 07302
Re: K090399
Trade/Device Name: Trois™ System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology
Regulatory Class: II Product Code: ONF Dated: May 31, 2009 Received: June 3, 2009
Dear Mr. Luzon:
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.
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
4
Page 2-Mr. Josef Luzon
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N J. Me erson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):
ko 9 0399
Device Name:
Trios™ System
Indications for Use:
The Trios™ system is indicated for long term stable, or permanent, hair reduction; for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions and for the treatment of mild to moderate inflammatory Acne Vulgaris.
Prescription Use X OR (Part 21 CFR 801 Subpart D)
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AeilkR. Ogle
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090399