(66 days)
The Elemé Medical SMOOTHSHAPES XV system is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
The SMOOTHSHAPES XV System featuring Photomology® technology is designed to temporarily reduce the appearance of cellulite. The proprietary Photomology technology combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum) to temporarily reduce the appearance of cellulite.
Photomology is based on the transcutaneous application of a dynamic combination of dual-band laser/light. The Photomology Module combines 650 nm light from LEDs and 915 nm light from laser diodes with mechanical massage (rollers) and vacuum (suction).
The provided text is a 510(k) summary for the SMOOTHSHAPES® XV System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain the detailed information about acceptance criteria or a specific study that proves the device meets those criteria, as requested in your prompt.
Specifically, the document focuses on regulatory approval based on demonstrating substantial equivalence to existing devices (Elemé SmoothShapes (K083629) and Syneron Velashape (K071872)) for the indications of use. It does not provide:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets, data provenance, or the number and qualifications of experts for ground truth.
- Information on adjudication methods, MRMC studies, or standalone algorithm performance.
- Specifics about the type of ground truth used or the size and ground truth establishment for a training set.
The document mostly outlines the administrative and regulatory aspects of the device's clearance.
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<100230
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
-2 2010
GENERAL INFORMATION
| Trade Name | SMOOTHSHAPES®XVSYSTEM |
|---|---|
| Classification Name | LASER INSTRUMENT, SURGICAL, POWERED |
| Class | II |
| Product Code | NUV |
| CFR section | 878.4810 |
| Device panel | General & Plastic Surgery |
| Legally marketedpredicate devices | Elemé SmoothShapes (K083629)Syneron Velashape (K071872) |
| Submitter | Elemé Medical, Inc.Heron Cove Office Park10 Al Paul Lane, Suite 102Merrimack, NH 03054 USA |
| Contacts | William H. McGrailVice President, Research & Development, Clinical & Regulatorybmcgrail@elememedical.comPhone:603-816-1603Fax: 603-882-4762 |
DEVICE DESCRIPTION
The SMOOTHSHAPES XV System featuring Photomology® technology is designed to temporarily reduce the appearance of cellulite. The proprietary Photomology technology combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum) to temporarily reduce the appearance of cellulite.
Photomology is based on the transcutaneous application of a dynamic combination of dual-band laser/light. The Photomology Module combines 650 nm light from LEDs and 915 nm light from laser diodes with mechanical massage (rollers) and vacuum (suction).
INTENDED USE
The Eleme Medical SMOOTHSHAPES XV system is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
SUBSTANTIAL EQUIVALENCE
The SMOOTHSHAPES XV System is substantially equivalent in its use and performance to the predicate devices with respect to technological features and intended use.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR - 2 2010
Elemé Medical, Inc. % Mr. William H. McGrail VP, Research & Development, Clinical & Regulatory 10 Al Paul Lane, Suite 102 Merrimack, New Hampshire 03054
Re: K100230
Trade/Device Name: SmoothShapes® XV System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: NUV Dated: March 08, 2010 Received: March 09, 2010
Dear Mr. McGrail:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Mr. William H. McGrail
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N Milkum
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K100230
Device Name: SMOOTHSHAPES® XV System
Indications for Use:
The Elemé Medical SMOOTHSHAPES XV system is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
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)
Dil RRegla for mixm
Bivision Sign-C Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K100230
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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.