(76 days)
Not Found
No
The summary describes a device based on selective thermolysis using optical and RF energy, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is indicated for non-invasive wrinkle treatment, which aims to address a cosmetic or medical condition and improve the patient's appearance or well-being, thus fitting the definition of a therapeutic device.
No
The device is described as being used for non-invasive wrinkle treatment, focusing on the principle of selective thermolysis to heat the skin. There is no indication from the provided text that it diagnoses any condition; its purpose is solely therapeutic (treatment).
No
The device description explicitly states it is a "device" used for treatment based on "optical and RF energy," which are hardware-based modalities. It also mentions an "applicator," which is a physical component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "non invasive wrinkles treatment." This is a therapeutic or aesthetic application, not a diagnostic one.
- Device Description: The description focuses on using electromagnetic energy to heat the skin for wrinkle treatment. This is a physical treatment method, not a method for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (on the body) for treatment.
N/A
Intended Use / Indications for Use
The Polaris WR is intended for non invasive wrinkle treatment.
The Polaris WR, ST applicator is indicated for non invasive wrinkles treatment.
Product codes (comma separated list FDA assigned to the subject device)
GEX, GEI
Device Description
The Polaris WR is a device that is used for non invasive wrinkle treatment. The Polaris WR treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively heat the skin without damaging the epidermis layer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
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)
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.
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SYNERON MEDICAL Ltd. Polaris WR / ST Applicator
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Syneron Medical Ltd., Tavor Bld., Submitter: Industrial Zone Yokneam Illit, Israel
Tel. +972.4.909-6200, Fax +972.4. 909-6202
Name of the Device: Polaris WR, ST Applicator
This is a Special 510(k) for the Polaris WR that was cleared Predicate Devices: under K031671.
Device Description: The Polaris WR is a device that is used for non invasive wrinkle treatment. The Polaris WR treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively heat the skin without damaging the epidermis layer.
The Polaris WR is intended for non invasive wrinkle treatment.
The modifications to the Polaris WR, ST applicator do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification is changing the output wavelengths spectrum from 780-980 nm in the original Polaris WR to 700 - 2000 nm on the new Polaris WR, ST applicator.
There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness.
December 22 2005
Dr. Amir Waldman
Amir Waldren
VP regulatory & clinical affairs Syneron Medical Ltd.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a bird or an abstract human figure with outstretched arms. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2006
Syneron Medical LTD c/o Dr. Amir Waldman VP. Regulatory Affairs Sultam Industrial Park P.O. Box 550 Yokneam Elite 20692. Israel
Re: K053616
Trade/Device Name: Polaris WR, ST Applicator 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: GEX, GEI Dated: February 23, 2006 Received: February 24, 2006
Dear Dr. Waldman:
We have reviewed your Scction 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 such additional controls. Existing major regulations affecting vour 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 nean 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); 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.
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Page 2 – Dr. Waldman
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 638-204) or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html
Sincerely yours,
Q.Mell
~ Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for Syneron Medical Ltd. The word "Syneron" is in a bold, sans-serif font, with the "S" stylized with a curved line extending from the top left. Below "Syneron" is the text "Medical Ltd." in a smaller, sans-serif font.
Sultam Industrial Park P.O.B. 550 Yokneam Elite 20692, Israel Tel: (972) 4 9096200 Fax: (972) 4 9096202
510(k) Number (if known) K053616.
Device Name
Indications For Use:
The Polaris WR, ST applicator is indicated for non invasive wrinkles treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over The Counter Use__________________________________________________________________________________________________________________________________________________________
lmal
(Optional Format 1-2-96)
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number_ Ko 5 361 6