(15 days)
The Aurora SR is intended for use in dermatology for superficial benign vascular and pigmented lesion treatment.
The modifications to the Aurora SR do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification is changing the light spectrum 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.
The Aurora SR is indicated for superficial benign vascular and pigmented lesion treatment.
The Aurora SR is a device that is used for superficial benign vascular and pigmented lesion treatment. The Aurora SR 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) vascular and pigmented lesions without damaging the surrounding tissues.
The provided document is a 510(k) summary for the Aurora SR / SR Applicator, which is a device used for superficial benign vascular and pigmented lesion treatment. This is a "Special 510(k)" submission, which typically means the changes to the device (in this case, changing the light spectrum output) do not affect the intended use or alter the fundamental scientific technology.
Crucially, this document does not contain any information regarding clinical studies, acceptance criteria, or specific performance data derived from such studies. Special 510(k)s often rely on the established safety and effectiveness of the predicate device and demonstrate that the modifications do not introduce new safety or effectiveness concerns. They generally do not require new clinical studies if the changes are minor and do not alter the fundamental mechanism of action or intended use.
Therefore, I cannot fulfill your request for the following information based on the provided text, as it is not present in the document:
- A table of acceptance criteria and the reported device performance: This information is not in the document.
- Sample size used for the test set and the data provenance: This information is not in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not in the document.
- Adjudication method for the test set: This information is not in the document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This information is not in the document. The device is not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a treatment device, not a diagnostic algorithm. This information is not in the document.
- The type of ground truth used: This information is not in the document.
- The sample size for the training set: This information is not in the document.
- How the ground truth for the training set was established: This information is not in the document.
Summary based on the provided text:
The document states that the modifications to the Aurora SR (changing the light spectrum output) do not affect the intended use or alter the fundamental scientific technology, and raise no new issues of safety or effectiveness. This type of submission relies on the predicate device's existing clearance (K031993) and demonstrates that the modifications do not negatively impact the safety and effectiveness already established. There is no mention of new studies being conducted to prove new acceptance criteria or device performance for this specific special 510(k) submission.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SYNERON MEDICAL Ltd. AURORA SR / SR Applicator
This summary of safety and effectiveness information is being submitted in This Summary of Sareey and vents of the SMDA 1990 and 21 CFR 807.92.
Syneron Medical Ltd., Tavor Bld., Submitter: Industrial Zone Yoqneam Illit, Israel Tel. +972.4.909-6200, Fax +972.4. 909-6202
Name of the Device: Aurora SR , SR Applicator
This is a Special 510(k) for the Aurora SR that was cleared Predicate Devices: under K031993.
- Device Description: The Aurora SR is a device that is used for superficial benign vascular and pigmented lesion treatment. The Aurora SR 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) vascular and pigmented lesions without damaging the surrounding tissues.
The Aurora SR is intended for use in dermatology for superficial benign vascular and pigmented lesion treatment.
The modifications to the Aurora SR do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification is changing the light spectrum 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.
Air Waldron
February 17 2005
Date
Dr. Amir Waldman VP Regulation and clinical affairs Syneron Medical Ltd.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 9 - 2005
Dr. Amir Waldman Dr. Allin Want, Regulation and Clinical Affairs Syneron Medical Ltd. P.O. Box 550 Industrial Zonc Yokneam Illit, 20692 Israel
Re: K050452
K030452
Trade/Device Name: Aurora SR, SR Applicator Trade/Device Name: Traine: Treater 21 CFR 878.4400 Regulation Name: Laser surgical instrument for use in general and Laser surgery and in dermatology; Electrosurgical cutting and coagulation device and accessories Regulatory Class: II
Product Code: GEX and GEI Dated: February 17, 2005 Received: February 22, 2005
Dear Dr. Waldman:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premainted institution of the indications
referenced above and have determined the device is substantially interstate referenced above and nave decimined the devices marketed in interstate for use stated in the encrosule) to regary maneted prouter of the Medical Tevice Ameralments, or to commerce prior to May 28, 1776, the enacertance with the provisions of the Federal Food, Drug. devices that have been recordance with approval of a premarket approval applications of the Act. The and Cosment Act (Act) that do not require approvate of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, l You may, merelore, market the device, bacycer to the generate for annual registration, listing of general controls provisions of the Frec mercial required in the supering misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). in If your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major and condition may be subject to such additional controller Entisting may - - - - - - - - - - - - - - - - - - - - - - 800 to 898 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - be found in the Code of Pederal Regarding your device in the Federal Register.
Please be advised that FDA`s issuance of a substantial equivalonee determination does not mean Please be advised that FDA S Issualice of a substance complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a delerimiation that your de ros by other Federal agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing ( 2 ) comply with all the Act s requirements, mending on the requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807), labeling (21 CFR Part 807), government 820); and if applicable. the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act): 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000
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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) This letter will anow you to begin maneting of substantial equivalence of your device to a legally premaired nother in the PDA miaing of basification 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 for your as 110 76-0115. Also, please note the regulation entitled, Colliact the Office of Compliance an (21 t ritification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely yours,
2
· Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number - - - - - - -K057452
Device Name___________________________________________________________________________________________________________________________________________________________________
Indications For Use: (separate page)
The Aurora SR is indicated for superficial benign vascular and pigmented lesion treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over The Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_11050452
§ 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.