(89 days)
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 (selective thermolysis using optical and RF energy).
No
The stated intended use is for hair removal and reduction, which is generally considered an aesthetic procedure, not a therapeutic one aimed at treating a disease or medical condition.
No
The device is indicated for the removal of unwanted hair and hair reduction, which are therapeutic rather than diagnostic purposes.
No
The device description clearly describes a device that utilizes optical and RF energy, which are hardware components, to achieve its intended use. It is not solely software.
Based on the provided information, the Aurora DS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the removal of unwanted hair from skin and hair reduction. This is a cosmetic or therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a device that applies optical and RF energy to the skin to target hair follicles. This is an external application of energy, not an in vitro test of a biological sample.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Aurora DS does not perform any such analysis of biological samples.
Therefore, the Aurora DS falls under the category of a therapeutic or cosmetic device, not an IVD.
N/A
Intended Use / 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.
Product codes
GEX, GEI
Device Description
The Aurora DS is a device indicated for the removal of unwanted hair from skin types I-VI, and to effect stable longterm, or permanent, hair reduction. The Aurora DS 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K 041969
OCT 1 9 2004
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., Sultam Industrial park, P.O.B. 550
Yokneam Elite 20692, Israel.
Tel. +972-4-909-6200 ext. 352, Fax +972-4-909-6202 |
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Name of the Device: Aurora DS
- The Aurora DS is substantially equivalent to a combination of 3 Predicate Devices: light powered surgical instruments (21 CFR 878.4810, procode GEX): Aurora DS, manufactured by Syneron Medical Ltd. and subject of K033586. Palomar StarLux, manufactured by Palomar medical products inc. and subject of K033549. Lovely system, manufactured by Msq Ltd. and subject of K033946
- Device Description: The Aurora DS is a device indicated for the removal of unwanted hair from skin types I-VI, and to effect stable longterm, or permanent, hair reduction. The Aurora DS 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 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.
Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences present. Therefore the Aurora DS should raise no new issues of safety or effectiveness.
217107
Total column
Date
Dr. Amir Waldman, Director regulatory affairs Syneron medical Ltd.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2004
Dr. Amir Waldman Director Regulatory Affairs Syneron Medical Ltd. P.O Box 550 Sultam Industrial Park Yokneam Elite, Israel 20692
Re: K041969
Trade/Device Name: Aurora DS 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, GEI Dated: July 19, 2004 Received: July 22, 2004
Dear Dr.Waldman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premium is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cheroours) to regars actment date of the Medical Device Amendments, or to commerce prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de rices mat have been recitablicat require approval of a premarket approval application (PMA). and Costietic rece (1101) that the nevice, subject to the general controls provisions of the Act. The 1 ou may, mercrore, market the Act include requirements for annual registration, listing of general controls proficition gractice, 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 be subject to sacer additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Teast be advisod that I Dr Crisean that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any I cueral surated and registments, 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 (21 CFR Part 820); and if applicable, the electronic form in the quinn 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) I his letter will anow you to begin manceing your avvee of your device of your device to a legally premarket notheation. The PDA miding of backanced volume 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 ac now on 5. Also, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the regu collact the Office of Complanes at (21 to 7 to 10 may of any 807.97). You may obtain "Misolallung by releveloc to premanters within the Act from the Division of Small other general information on your response 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)
Device Name
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use سا (Per 21 CFR 801.109) OR
Over The Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number Ko 41969