(27 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 sets typically associated with AI/ML development.
No
The device is intended for non-invasive hair removal, which is typically considered a cosmetic procedure and not a therapeutic one aimed at treating a disease or condition.
No
The document explicitly states the intended use of the Aurora DS is for non-invasive hair removal, not diagnosis.
No
The device description explicitly states it is a "device" used for non-invasive hair removal based on optical and RF energy, implying hardware components are involved in delivering this energy.
Based on the provided information, the Aurora DS is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The stated intended use is "non-invasive hair removal" in dermatology. 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 optical and RF energy to target hair follicles. This is a physical treatment method, not a diagnostic test.
- 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 disease, condition, or physiological state
- Using reagents or assays
In summary, the Aurora DS is a device used for a physical treatment (hair removal) and does not fit the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
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, GEI
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
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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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
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The string is "K03358p" and is written in a cursive style.
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.
- Submitter: Syneron Medical Ltd., Appolo Bld., Industrial Zone Yoqneam Illit, Israel Tel. +972.4.909-7424, Fax +972.4. 909-7417
Name of the Device: Aurora DS
| Predicate Devices: | This is a Special 510(k) for the Aurora
DS that was cleared under K031988. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
The modifications to the Aurora DS do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification an increase in the light energy output. There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness.
Arie Waller
6 November 2003
Dr. Amir Waldman Director, Regulatory affairs Syneron Medical Ltd.
Date
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized caduceus, a symbol often associated with healthcare and medicine. The emblem consists of a staff with two snakes coiled around it, and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2003
Dr. Amir Waldman Director, Regulatory Affairs Syneron Medical Ltd. Sultam Industrial Park P.O.B. 550 Yokneam Elite 20692 Israel
Re: K033586 Trade/Device Name: Aurora DS 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: November 6, 2003 Received: November 14, 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 docs not mean that FDA has made a dctermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencics. 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 yours,
Muriam 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
033586 510(k) Number
Device Name Aurora DS
Indications For Use: (separate page)
The Aurora DS is indicated for non-invasive hair removal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_A (Per 21 CFR 801.109)
Over The Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
uriam C. Provost
(Division of General, Restorative and Neurological Devices
510(k) Number K033586