(47 days)
Not Found
No
The device description focuses on the physical mechanisms of action (heat, light, RF energy, massage, vacuum) and does not mention any computational or algorithmic components indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for "relief of minor muscle aches and pain" and "relief of muscle spasm," which clearly describes therapeutic effects.
No
The device is indicated for therapeutic purposes (relief of pain, circulation improvement, cellulite and circumference reduction) rather than for identifying or detecting diseases or conditions.
No
The device description clearly states the device applies heat and mechanical manipulation, which are hardware-based functions, not solely software.
Based on the provided information, the VelaShape device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (relief of muscle aches/pain/spasm, improved blood circulation, cellulite reduction, thigh circumference reduction) are all related to treating or affecting the body directly. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The device description details a treatment method involving heat and mechanical manipulation applied to the body. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the VelaShape is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.
Product codes
NUV
Device Description
The VelaShape treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted RF energy, and the mechanical manipulation is derived from massage and/or vacuum.
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 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
Ko 7 1872
510/k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. VELASHAPE
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Medical Industrial Park. P.O.B. રુડી, Syneron Ltd.. Submitter: Yokneam Illit, 20692, Israel. Tel. +972-73-244-2200 ext. 591, Fax +972-73-244-2202
Name of the Device: VelaShape
This is special 510k for the VelaShape (name change from Predicate Devices: VelaSmooth, Shaper) that is substantially equivalent to the following cleared device: VelaSmooth, Shaper, manufactured by Syneron Medical Ltd. and subject of K050397 and of K070092.
- Device Description: The VelaShape treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted RF energy, and the mechanical manipulation is derived from massage and/or vacuum.
The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite (K050397). The VelaShape is also indicated for temporary reduction of thighs circumferences (K070092).
The modification of the increased RF power of the VelaShape does not affect the intended use or alter the fundamental scientific technology background of the device, nor that it affect the mode of use. There are no labeling changes that affect the intended use of the device.
The modification of the increased RF power raises no new issues of safety or effectiveness.
yomi T.
August 16, 2007 Date
or of Clinical & Regulatory / 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 consists of a stylized eagle or bird-like symbol with three overlapping shapes that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Syneron Medical Ltd. % Yoni Iger, Ph.D. Director of Clinical & Regulatory Affairs Industrial Park P.O. Box 550, Yokneam Illit 20692, Israel
AUG 2 2 2007
Re: K071872 Trade/Device Name: VelaShape 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: July 4, 2007 Received: July 6, 2007
Dear Dr. Iger:
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
2
Page 2 - Yoni Iger, Ph.D.
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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Samuel B. Edgar
FOR
Mark N. Melkersón 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): K071872
Device Name: VelaShape
Indications for Use:
The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Turner W. Cooper
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K071872