(20 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 terms, image processing, or data-driven performance metrics.
Yes
The device is described as being used for the "treatment of vascular lesions," which is a therapeutic application.
No
The device is described as being used for the treatment of vascular lesions, not for diagnosis. The description focuses on how it damages the hair follicle.
No
The device description explicitly states it is used for "treatment of vascular lesions" based on "optical and RF energy," indicating it is a hardware device that delivers energy for therapeutic purposes, not a software-only device.
Based on the provided information, the Polaris LV is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states "treatment of vascular lesions." This indicates a therapeutic purpose, not a diagnostic one.
- Device Description: The description explains the mechanism of action is based on selective thermolysis for treatment, not for analyzing samples or providing diagnostic information.
- 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.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Polaris LV is a therapeutic device used to treat a condition directly on the patient.
N/A
Intended Use / Indications for Use
The Polaris LV is intended for use in dermatology for treatment of vascular lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX, GEI
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 to the hair follicle 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 (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.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENES
SYNERON MEDICAL Ltd. Polaris LV / LVA 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 LV , LVA Applicator
This is a Special 510(k) for the Polaris LV that was cleared Predicate Devices: under K030186.
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 to the hair follicle without damaging the surrounding tissues.
The Polaris LV is intended for use in dermatology for treatment of vascular lesions.
The modifications to the Polaris LV do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification is increasing the laser energy density output, still with in the range of predicate devices.
There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness.
August 22 20005
tuir Waldman
Dr. Amir Waldman
VP regulatory & clinical affairs Syneron Medical Ltd.
1
Name of Manufacturer: Synergy Medical Ltd.
Laser Model Name and Number: Polaris LV
Laser Type: -(Circle all that apply)-
Alexandrite, Argon, CO₂, Copper-Vapor, (Diode), Dye, Nd:YAG, Erb: Y
Hol: YAG, Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other_
Indications in this Application: Treatment for dermatological Vascular
lesions.
List of Examples:
| Labels | Values |
|---|---|
| FDA Document Control Number | K 052324 |
| FDA Product Code | GEX |
| Reviewer Computer Initials | SPB |
| Date of Clearance Letter |
Basis of Approval: -(Circle all that apply)-
Predicate Device (PD), Clinical Data (CD), Animal Data (AD
Specifications (SPECS), Bench Test Data (BTD), Historical Informati
(HI), Other
Description of Laser:
Operation Modes: -(Circle all that apply)-
CW, (Pulsed), Q-Switched, Mode Locked, Contact, Free beam, Other
Wavelength(s) in Nanometers: 780-980
Power/Energy Range (watts/joules): 350 J/cm² (optical) + 100 J/cm³ (RF) Pul
Width: 100 msec Repetiti
Rate: 1 Hz Delivery System(s
Laser beam is transmitted through the light guide out of the applicator.
Comments: Laser and RF Energy are combined for the treatment.
This special 510(K) is for enhancing the optical fluence from 140 to
350 J/cm²
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the left, and two wavy lines below the eagle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circle around the eagle.
SEP 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Amir Waldman VP Regulatory & Clinical Affairs Syneron Medical Ltd., Tavor Building Industrial Zone P.O.B. 550 Yokneam Illit, Israel 20692
Re: K052324 Trade/Device Name: Polaris LV, LVA 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: August 22, 2005 Received: August 25, 2005
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.
3
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) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Borlund
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K US 2324
Device Name: Polaris LV, LVA Applicator
Indications For Use: The Polaris LV is intended for use in dermatology for treatment of vascular lesions.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shatiav Buchup for WXM
(Division Division of General, Restorative, and Neurological Devices
510(k) Number K052324
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