(63 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.
No.
The device is indicated for non-invasive hair removal, which is a cosmetic procedure, not a therapeutic one aimed at treating a disease or medical condition.
No
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for non invasive hair removal," which is a treatment, not a diagnosis.
No
The device description explicitly states it is a "device that is used for non invasive hair removal" and describes the treatment based on "optical and RF energy," which are hardware-based modalities. The predicate devices are also hardware-based hair removal systems.
Based on the provided information, the Polaris DS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "non invasive hair removal." This is a cosmetic or therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a device that uses electromagnetic energy to target hair follicles on the body. This aligns with a device used for a physical treatment, not for analyzing biological samples.
- 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 diagnostic information about a 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 the diagnosis, monitoring, or treatment of diseases or conditions. The Polaris DS's function is to physically remove hair from the body.
N/A
Intended Use / Indications for Use
The Polaris DS is indicated for non invasive hair removal.
Product codes
GEX
Device Description
The Polaris DS is a device that is used for non invasive hair removal. The Polaris DS 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 DS is intended for use in dermatology for non invasive hair removal.
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)
K021149, K013028, K010005, K003993
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
024064 F
FEB 1 0 2003
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. POLARIS DS
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 DS
Predicate Devices: The Polaris DS is substantially equivalent to a combination of four laser powered surgical instruments (21 CFR 878.4810, procode GEX): Aurora DS, manufactured by Syneron Medical Ltd. and subject of K021149; SLP 1000, manufactured by Palomar Medical Technologies Inc. and subject of K013028; PhotoGenica DL, manufactured by Cynosure Inc. and subject Dornier Medilas of K010005: D SkinPulse Laser. manufactured by DornierMedTech, and subject of K003993.
- Device Description: The Polaris DS is a device that is used for non invasive hair removal. The Polaris DS 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 DS is intended for use in dermatology for non invasive hair removal.
Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no signiticant differences present. Therefore the Polaris DS should raise no new issues of safety or effectiveness.
Dec. 1, 202
Air Waldman
Dr. Amir Waldman, Director regulatory affairs Syneron medical Ltd.
Date
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles.
FEB 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Amir Waldman Director, Regulatory Affairs Syneron Medical Ltd. Sultam Industrial Park POB 550 Yokneam Elite Israel 20692
Re: K024064 Trade Name: Polaris DS 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 Dated: December 4, 2002 Received: December 9, 2002
Dear Dr. Waldman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
2
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 vours.
Sincerely yours,
Mark N Milliman
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) KO2 YOG4
Device Name___Polaris DS.
Indications For Use:
The Polaris DS is indicated for non invasive hair removal.
(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)
Mark N. Millerson
of General, Restorative Neurolozical Devices
Number K02 4064