(83 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the physical principles of the device.
Yes
The device is indicated for "treatment of vascular lesions," which is a therapeutic purpose.
No
The device is indicated for "treatment of vascular lesions" and is described as performing selective thermolysis to "selectively damage vascular lesions". These actions are therapeutic, not diagnostic.
No
The device description explicitly states it uses optical and RF energy, which are hardware-based modalities for treatment. It is not solely software.
Based on the provided information, the Polaris LV is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "treatment of vascular lesions." This is a therapeutic application, not a diagnostic one.
- Device Description: The description explains how the device works to treat lesions using electromagnetic energy. It does not mention analyzing samples from the body (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
The Polaris LV is a therapeutic device used for a medical procedure.
N/A
Intended Use / Indications for Use
The Polaris LV is intended for use in dermatology for treatment of vascular lesions.
The Polaris LV is indicated for treatment of vascular lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Polaris LV is a device that is used for treatment of vascular lesions. The Polaris LV 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 damage vascular lesions without damaging the surrounding tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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.
K024064, K980537, K013028, K020339
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
Image /page/0/Picture/0 description: The image shows a handwritten number, "1030186". The numbers are written in black ink on a white background. The handwriting is somewhat stylized, with some numbers slightly overlapping.
APR 1 4 2003
Sultam Industrial Park P.O.B. 550 Yokneam Elite 20692. Israel Tel: (972) 4 9097424 Fax: (972) 4 9097417
Medical Ltd
Attachment 2 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. POLARIS LV
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 LV
- Predicate Devices: The Polaris LV is substantially equivalent to a combination of the following devices: the Polaris DS, manufactured by Syneron Medical Ltd. and subject of K024064; the PhotoDerm Nd:YAG Accessory, manufactured by ESC Medical Ltd., and subject of K980537; the SLP 1000, manufactured by Palomar Medical Technologies Inc., and subiect of K013028: the Dornier Medilas D SkinPulse Laser, manufactured by DornierMedTech, and subject of K020339.
- Device Description: The Polaris LV is a device that is used for treatment of vascular lesions. The Polaris LV 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 damage vascular lesions without damaging the surrounding tissues.
The Polaris LV is intended for use in dermatology for treatment of vascular lesions.
Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit. Therefore the Polaris DS should raise no new issues of safety or effectiveness.
12, FEB 2023
Amin WALDMAN
Date
Dr. Amir Waldman. Director regulatory affairs Syneron medical Ltd.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, formed by three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
APR 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Amir Waldman, M.D. Director, Regulatory Affairs Syneron Medical Ltd. Sultam Industrial Park P.O.B. 550 Yokneam Elite 20692, Israel
Re: K030186 Trade/Device Name: Polaris LV Regulation Number: 21 CFR 878.4810 Regulation Names: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Codes: GEX Dated: January 17, 2003 Received: January 21, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Amir Waldman, M.D.
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
b Mahn N Millerson
Celia M. Witten, Ph.D., M.D. 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)_Ko36 | J
Device Name___ Polaris LV.
Indications For Use:
The Polaris LV is indicated for treatment of vascular lesions.
(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__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
for Mark N Millhum
(Division Sign-Off)
and IV
510(k) Number
KOSOI