(186 days)
Not Found
No
The summary describes a device based on selective thermolysis using optical and RF energy, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions or performance studies related to AI/ML.
Yes
The device is indicated for non-invasive wrinkles treatment, which directly addresses a health-related condition or aesthetic concern with a therapeutic intent.
No
Explanation: The device is indicated for non-invasive wrinkle treatment, which is a therapeutic rather than a diagnostic purpose. It describes how it treats the condition, not how it identifies or analyzes it.
No
The device description explicitly states it is a "device" that uses "optical and RF energy" for treatment, indicating it includes hardware components for energy delivery.
Based on the provided information, the Polaris WR is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "non invasive wrinkles treatment." This is a therapeutic or aesthetic treatment applied directly to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a device that uses electromagnetic energy (optical and RF) to treat wrinkles based on selective thermolysis. 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 of diseases or conditions
The Polaris WR is a therapeutic device used for a cosmetic or medical treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Polaris WR is indicated for non invasive wrinkles treatment.
Product codes
GEX, GEI
Device Description
The Polaris WR is a device that is used for non invasive wrinkles treatment. The Polaris WR treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF cnergy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage to the treatment target without damaging the surrounding tissues.
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
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
Not Found
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
K03167|
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. POLARIS WR
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
| Submitter: | Syneron Medical Ltd., Sultam Industrial park, P.O.B. 550,
Yokneam Elite 20692, Israel.
Tel. +972-4-909-7424 ext. 7604, Fax +972-4-909-7417 |
| ------------ | -------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Name of the Device: Polaris WR
- Predicate Devices: The Polaris WR is substantially equivalent to a combination of 3 laser powered surgical instruments (21 CFR 878.4810, procode GEX): Polaris LV, manufactured by Syneron Medical Ltd. and subject of K030186; Coolglide, manufactured by Altus Medical Inc. and subject of K023954; ThermaCool TC, Manufactured by Thermage Inc. and subject of K030142.
- Device Description: The Polaris WR is a device that is used for non invasive wrinkles treatment. The Polaris WR treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF cnergy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage to the treatment target without damaging the surrounding tissues.
The Polaris WR is intended for use in dermatology for non ivasive wrinkles treatment.
Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences present. Therefore the Polaris WR should raise no new issues of safety or effectiveness.
September, 4,2003
Amir Walden
Dr. Amir Waldman, Director regulatory affairs Syneron medical Ltd.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC = 1 2003
Dr. Amir Waldman Director, Regulatory Affairs Syneron Medical Ltd. Sultam Industrial Park P.O.B. 550 Yokneam Elite 20692, Isracl
Re: K031671 Trade/Device Name: Polaris WR Regulation Number: 21 CFR 878.4810, 878.4400 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology; Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEX, GEI Dated: September 4, 2003 Received: September 8, 2003
Dear Dr. Waldman:
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 such 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 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. Amir 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 (301) 594-4659. 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) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
W Cclia M. Witten, Ph.D., M.I). Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known) K031671.
Device Name___Polaris WR.
Indications For Use:
The Polaris WR 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_L (Per 21 CFR 801.109) OR '
Over The Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031671