(14 days)
The Aurora DS is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction
The Aurora DS is a device that is used for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. 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) vascular and pigmented lesions without damaging the surrounding tissues.
The provided text describes a 510(k) summary for the Syneron Medical Ltd. Aurora DS / DS Applicator, which is a device used for hair removal. This document is a regulatory submission for a device modification, specifically changing the light spectrum output.
Based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those criteria, as typically understood for AI/ML device performance.
The document states: "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 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."
This suggests that the 510(k) submission is for a minor modification that is not expected to change the device's performance from its previously cleared version. Therefore, a new, extensive performance study with acceptance criteria, as one would expect for a novel or significantly modified device, is not presented or required in this particular 510(k) summary. The FDA's letter confirms substantial equivalence to a predicate device, which means the safety and effectiveness are considered to be similar to an already legally marketed device.
Therefore, I cannot provide the requested table and information, as the input document does not contain details about specific performance acceptance criteria or a study proving those criteria for the modified device.
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APR I 2 2005
510(k) SUMMARY OF SAFETY AND EFF
SYNERON MEDICAL Ltd. AURORA DS / DS Applicator
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., Tavor Bld., Industrial Zone Yokneam Illit, Israel Tel. +972.4.909-6200, Fax +972.4. 909-6202
Name of the Device: Aurora DS , DS Applicator
Predicate Devices: This is a Special 510(k) for the Aurora DS that was cleared under K041969.
Device Description: The Aurora DS is a device that is used for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. 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) vascular and pigmented lesions without damaging the surrounding tissues.
The Aurora DS is intended for use in dermatology for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction.
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 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.
March 24 20005
Dr. Amir Waldman
Amir Walen
VP regulatory & clinical affairs Syneron Medical Ltd.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
APR 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Amir Waldman VP, Regulatory and Clinical Affairs Syneron Medical Ltd. Industrial Zone Yokneam Illit, 20692 P.O.B. 550, Isreal
Re: K050796
Trade/Device Name: Aurora DS, DS Applicator 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: March 24, 2005 Received: March 29, 2005
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 prexted 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 (240) 276-0120 . 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/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K050 796
Device Name: Aurora DS, DS Applicator
Indications For Use: The Aurora DS is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 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.