SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V

K100230 · Eleme Medical, Inc. · NUV · Apr 2, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100230
• Device Name: SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V
• Applicant: Eleme Medical, Inc.
• Product Code: NUV · General, Plastic Surgery
• Decision Date: Apr 2, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

SMOOTHSHAPES XV System utilizes Photomology technology to treat cellulite and muscle-related conditions. Device inputs include electrical power to drive dual-band laser/light sources (650 nm LEDs and 915 nm laser diodes) and mechanical components. Operation involves transcutaneous application of light energy combined with mechanical massage via contoured rollers and vacuum suction. System is intended for use in clinical settings by trained operators. Output is the physical application of heat and mechanical manipulation to the skin and underlying tissue. This process aims to improve local blood circulation, relieve muscle spasms/aches, and temporarily reduce cellulite appearance, providing aesthetic and therapeutic benefits to the patient.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

System utilizes Photomology technology combining 650 nm LED light and 915 nm laser diodes with mechanical massage rollers and vacuum suction. Device is a powered laser surgical instrument (21 CFR 878.4810).

Indications for Use

Indicated for individuals seeking relief from minor muscle aches, pain, and muscle spasms, as well as those desiring temporary improvement in local blood circulation and temporary reduction in the appearance of cellulite.

Regulatory Classification

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

• Elemé SmoothShapes (K083629)
• Syneron Velashape (K071872)

Submission Summary (Full Text)

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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 marketed<br>predicate devices | Elemé SmoothShapes (K083629)<br>Syneron Velashape (K071872) |
| Submitter | Elemé Medical, Inc.<br>Heron Cove Office Park<br>10 Al Paul Lane, Suite 102<br>Merrimack, NH 03054 USA |
| Contacts | William H. McGrail<br>Vice President, Research & Development, Clinical & Regulatory<br>[e-mail]<br>Phone:[phone]<br>Fax: [phone] |

#### 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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Dil RRegla for mixm

Bivision Sign-C Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K100230

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