(113 days)
Not Found
No
The device description focuses on the physical mechanisms of action (heat, light, RF energy, mechanical manipulation) and does not mention any computational or data-driven components indicative of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation, which are all therapeutic benefits.
No
Explanation: The device is indicated for therapeutic purposes such as pain relief, improvement of blood circulation, and reduction of cellulite appearance. It does not mention any function for diagnosing diseases or conditions.
No
The device description explicitly states the application of heat, light energy, RF energy, and mechanical manipulations, indicating a hardware-based device.
Based on the provided information, the Vela smooth, Shaper is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed (relief of muscle aches and pain, muscle spasm, improved blood circulation, cellulite reduction) are all related to treating or affecting the body directly, not analyzing samples taken from the body.
- Device Description: The device description details the application of heat, light energy, RF energy, and mechanical manipulation to the skin. This is a physical treatment method, not an in vitro diagnostic process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Vela smooth, Shaper's function is entirely external and therapeutic.
N/A
Intended Use / Indications for Use
The Vela smooth, Shaper is indicated for the relief of minor muscle aches and pain. Relief of muscle spam Temporary improvement of local blood circulation. Temporary reduction in the appearance of cellulite.
Product codes (comma separated list FDA assigned to the subject device)
NUV
Device Description
The Vela smooth, Shaper treatment is based on the simultaneous application of heat to the tissue with light energy at a controlled Infrared wavelength, conducted RF energy, and mechanical manipulations of the skin.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K990445, K013197, K003538, K031988, K030142
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K050397
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. VELASMOOTH, SHAPER
This summary of safety and effectiveness information is being submitted in accordance with the requircments of the SMDA 1990 and 21 CFR 807.92.
Syneron Medical Ltd., Sultam Industrial park, P.O.R.550, Submitter: Yokneam Elite 20692, Israel. Tel. +972-4-909-6200 ext. 352, Fax +972-4-909-6202
Name of the Device: Vela smooth, Shaper
- Predicate Devices: Vela smooth, Shaper is substantially equivalent to a combination of the following devices: LPG therapeutic massager, manufactured by LPG systems and subject of K990445. WS-501 Heat lamp, manufactured by Lhasa Medical Inc. and subject of K013197. TDP CQ-27 heat lamp, manufactured by Lhasa Medical, Inc. and subject of K003538. Aurora DS, manufactured by Syneron medical Ltd. and subject of K031988. ThermaCool TC, manufactured by Thermage Inc. and subject of K030142.
- Device Description: The Vela smooth, Shaper treatment is based on the simultaneous application of heat to the tissue with light energy at a controlled Infrared wavelength, conducted RF energy, and mechanical manipulations of the skin.
The Vela smooth, Shaper is indicated for the relief of minor muscle aches and pain. Relieve of muscle spasm. Temporary improvement of local blood circulation. Temporary reduction in the appearance of cellulite.
Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit. Therefore the Vela smooth, Shaper should raise no new issues of safety or effectiveness.
February 13, 2005
Date
Jur Wahler
Dr. Amir Waldman, Director regulatory affairs Syneron medical Ltd.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "U.S. Department of Health & Human Services - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird with three stylized lines representing its wings or body.
JUN 9 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Syneron Medical, LTD. C/o Mr. Donald E. Segal Alston & Bird, LLP 601 Pennsylvania Avenue, N.W. North Building, 10th floor Washington, District of Columbia 20004
Re: K050397
Trade/Device Name: Vela smooth, Shaper 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: NUV Dated: May 23,2005 Received: May 23,2005
Dear Mr. Segal:
We have reviewed vour 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 iinnual 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 regulationsadministered 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.
2
Page 2 - Mr. Donald E. Segal
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 (240) 276-0115 . 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/cdrl/industry/support/index.html.
Sincerety yours,
Miriam C. Provost, P
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
3
Indications for Use
| 510(k) Number (if known); | K050397 |
|---|---|
| Device Name: | Vela smooth, Shaper. |
| Indications For Use: | The Vela smooth, Shaper is indicated for the relief |
| of minor muscle aches and pain. Relief of muscle spam | |
| Temporary improvement of local blood circulation. | |
| Temporary reduction in the appearance of cellulite. |
区 Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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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Sivision Sign-Off) Division of Consint, Fertorative and Neurological Devices
1 20 K ) Mozriber __ K OSO 397
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