(110 days)
Not Found
No
The summary 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 hair removal and permanent hair reduction, which are considered therapeutic treatments as they aim to modify the body's condition for cosmetic or medical reasons.
No
The device is indicated for hair removal and permanent hair reduction, which are therapeutic rather than diagnostic purposes.
No
The device description clearly states it is a device indicated for hair removal and permanent hair reduction based on the principle of selective (electromagnetic) thermolysis, which involves the application of optical and RF energy. This indicates a hardware component is necessary to deliver this energy, making it a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal and permanent hair reduction. This is a therapeutic/cosmetic procedure performed directly on the patient's body.
- Device Description: The description details a device that uses optical and RF energy to target hair follicles. This is an external energy-based device, not a device that analyzes biological samples in vitro (outside the body).
- Lack of IVD Characteristics: The document 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
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely different.
N/A
Intended Use / Indications for Use
The Polaris DS / Comet is indicated for hair removal, permanent hair reduction. The Polaris DS / Comet is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.
Product codes
GEX, GEI
Device Description
The Polaris DS / Comet is a device indicated for hair removal, permanent hair reduction. The Polaris DS is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin. The Polaris DS / Comet 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K024064, K031671, K003614, K030805
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. POLARIS DS / Comet
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., Sultam Industrial park, P.O.B. 550, Submitter: Yokneam Elite 20692, Israel. Tel. +972-4-909-7424 ext. 7604, Fax +972-4-909-7417
Name of the Device: Polaris DS / Comet
- The Polaris DS /Comet is substantially equivalent to a Predicate Devices: combination of four laser powered surgical instruments (21 CFR 878.4810, procode GEX): Polaris DS, manufactured by Syneron Medical Ltd. and subject of K024064. Polaris WR, manufactured by Syneron Medical Ltd. and subject of K031671. LightSheer, manufactured by Lumenis Inc. and subject of K003614. Mythos 500, manufactured by Msq Ltd. and subject of K030805
- Device Description: The Polaris DS / Comet is a device indicated for hair removal, permanent hair reduction. The Polaris DS is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin. The Polaris DS / Comet 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 hair removal, permanent hair reduction. The Polaris DS is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.
Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences present. Therefore the Polaris DS / Comet should raise no new issues of safety or effectiveness.
July 15 2007
Amelia Weber
Dr. Amir Waldman, Director regulatory affairs Syneron medical Ltd.
Date
1
Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2004
Dr. Amir Waldman Director, Regulatory Affairs Syneron Medical Ltd. Sultam Industrial Park P.O.B 550 Yokneam Elite 20692. Israel
Re: K041959 Trade/Device Name: Polaris DS / Comet Regulation Number: 21 CFR 878.4810, 21 CFR 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: October 21, 2004 Received: October 25, 2004
Dear Dr. Waldman:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrobare) to regary to regars and the Medical Device Amendments, or to conninered province with the provisions with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmeter Act (1107 market the device, subject to the general controls provisions of the Act. The r ou may, dictions provisions of the Act include requirements for annual registration, listing of general bonus provisions of visitive, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back additions, 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 I tease be activities that I Driseanter over device complies with other requirements of the Act that I Dri has Intacted and regulations administered by other Federal agencies. You must of any I cataled and registments, including, but not limited to: registration and listing (21
2
Page 2 - Dr. Amir Waldman
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It I all 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to organ finding of substantial equivalence of your device to a legally prematicate 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 If you desire specific advice 10. 900 and 11. Also, please note the regulation entitled, Contact the Office or Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other geleral informational 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
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)_ K_041959
Device Name___ Polaris DS / Comet.
Indications For Use:
The Polaris DS / Comet is indicated for hair removal, permanent hair The Fouris DS / Comet is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.
(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)
Miriam C. Provost
(Division Division of Ge Rest - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - and Neurological Devices.
510(k) Number K041959