(90 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 typically associated with AI/ML devices.
No.
The device is described as being used for non-invasive hair removal, which is typically considered a cosmetic procedure rather than a therapeutic medical treatment. While it affects a body function (hair growth), it does so for aesthetic purposes rather than to treat a disease, injury, or other medical condition.
No
The device is used for non-invasive hair removal, which is a treatment, not a diagnostic purpose.
No
The device description explicitly states it is a "device that is used for non-invasive hair removal" and mentions "optical and RF energy," which are hardware components. The predicate devices also appear to be hardware-based hair removal systems.
Based on the provided information, the Aurora DS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The stated intended use is "non invasive hair removal" in dermatology. This is a therapeutic or cosmetic procedure performed on the body, not a diagnostic test performed on samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: The description focuses on the mechanism of action (selective thermolysis using optical and RF energy) for hair removal, which is a physical interaction with the body, not an analysis of biological samples.
- 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.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the Aurora DS is a therapeutic or cosmetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aurora DS is intended for use in dermatology for non invasive hair removal.
The Aurora DS is indicated for non-invasive hair removal.
Product codes
GEX
Device Description
The Aurora DS is a device that is used for non-invasive hair removal. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) hair and 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
dermatology
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
Based upon an analysis of the overall performance characteristic for the device Syneron medical Ltd. believes that no significant differences exits. Therefore the Aurora DS should raise no new issues of safety or effectiveness.
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. AURORA 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.
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Syneron Medical Ltd., 18 Coplevich Street, Or Akiva, 30600 Submitter: Israel. Tel. +972.4.610-1118, Fax +972.4.610-1189
Name of the Device: Aurora DS -
The Aurora DS is substantially equivalent to a combination of Predicate Devices: the. EpiLight, manufactured by ESC Medical Systems Ltd. and subject of K991935. the Compu-Blend, manufactured by R.A. Fischer Co. Inc. and subject of K954031, and the ThermaCool, manufactured by Thermage Inc. and subject of K000944.
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Device Description: The Aurora DS is a device that is used for non-invasive hair removal. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) hair and follicle without damaging the surrounding tissues.
The Aurora 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 significant differences exits. Therefore the Aurora DS should raise no new issues of safety or effectiveness.
April, 4
Avis Walch
Date
Dr. Amir Waldman, Director regulatory affairs Syneron medical Ltd.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Amir Waldman Director of Regulatory Affairs Syneron Medical Ltd. 18 Coplevich Street P.O.B. 11033 Or-Akiva 30600 Israel
Re: K021149 Trade/Device Name: Aurora DS Regulation Number: 878.4810. 878.4400, 878.5350 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology; Electrosurgical cutting and coagulation device and accessories; Needle-type epilator Regulatory Class: II Product Code: GEX Dated: April 7, 2002 Received: April 10, 2002
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9 2002
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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), 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.
Hyl Rhodes
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
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K 021159 510(k) Number (if known)__ Device Name____Aurora DS__
Indications For Use:
The Aurora 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)
Hyk. Rlunde
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KOZIIY9 510(k) Number ________________________________________________________________________________________________________________________________________________________________