← Product Code [NUV](/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV) · K050397 # VELASMOOTH, SHAPER (K050397) _Syneron Medical, Ltd. · NUV · Jun 9, 2005 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K050397 ## Device Facts - **Applicant:** Syneron Medical, Ltd. - **Product Code:** [NUV](/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV.md) - **Decision Date:** Jun 9, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended 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. ## Device Story VelaSmooth/Shaper device utilizes simultaneous application of infrared light energy, conducted RF energy, and mechanical skin manipulation. Device intended for relief of minor muscle aches/pain, muscle spasms, temporary improvement of local blood circulation, and temporary reduction in cellulite appearance. Operated by clinical staff in professional settings. Output consists of thermal and mechanical energy applied to tissue; healthcare providers use device to provide therapeutic massage and heat therapy. Benefits include symptomatic relief and aesthetic improvement. ## Clinical Evidence No clinical data provided; substantial equivalence is based on performance characteristics and comparison to legally marketed predicate devices. ## Technological Characteristics Device combines infrared light energy, conducted RF energy, and mechanical skin manipulation. Class II device (21 CFR 878.4810). ## Regulatory 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. ## Predicate Devices - LPG therapeutic massager ([K990445](/device/K990445.md)) - WS-501 Heat lamp ([K013197](/device/K013197.md)) - TDP CQ-27 heat lamp ([K003538](/device/K003538.md)) - Aurora DS ([K031988](/device/K031988.md)) - ThermaCool TC ([K030142](/device/K030142.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) ball Sivision Sign-Off) Division of Consint, Fertorative and Neurological Devices 1 20 K ) Mozriber __ K OSO 397 Page 1 of _ 1 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K050397](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K050397) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com