The Elemé Medical SmoothShapes® 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 Description

The SmoothShapes® System featuring Photomology® technology is designed to offer an innovative way to safely and effectively treat cellulite. The proprietary Photomology technology combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum) to reduce the appearance of cellulite.

AI/ML Overview

The provided text is a 510(k) summary for the Elemé Medical SmoothShapes® System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, study details, or performance data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, or specific study types like MRMC or standalone performance. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical study demonstrating meeting specific performance criteria.

Summary

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ELEMÉ MEDICAL, INC.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

GENERAL INFORMATION

K1183629

FEB 1 9 2009

Trade Name	SMOOTHSHAPES® SYSTEM
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 (K053611; K061603)Syneron Velashape (K071872)
Submitter	Elemé Medical, Inc.Heron Cove Office Part10 Al Paul Lane, Suite 102Merrimack, NH 03054
Contacts	Michail A. Pankratov, Vice President, Clinical & Regulatory Affairsmpankratov@elememedical.comPhone: 1-603-816-1645Fax: 1-603-882-4762

DEVICE DESCRIPTION

INTENDED USE

SUBSTANTIAL EQUIVALENCE

The SmoothShapes® Systems is substantially equivalent to the predicate devices with respect to technological features and intended use.

The modification of increased optical power does not affect the fundamental scientific technology of the device or its Intended use. The modification of increased optical power does not raise new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a scanned image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Eleme Medical, Inc. % Michail Pankratov, MD, PhD VP, Regulatory & Clinical Affairs 10 Al Paul Lane, Suite 102 Merrimack, New Hampshire 03054

FEB 1 9 2009

Re: K083629

Trade/Device Name: SMOOTHSHAPES® System 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: January 22, 2009 Received: January 23, 2009

Dear Dr. Pankratov:

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, geod 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

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Page 2 - Michail Pankratov, MD, PhD

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) Eor questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devees and Kadiological Health .

Enclosure

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SMOOTHSHAPES Special 510(k)

ELEMÉ MEDICAL, INC.

INDICATIONS FOR USE

参考

4083629

510(k) Number (if known):

Device Name: SMOOTHSHAPES® System

Indications for Use:

Prescription Use ﻪ (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)

Nathalie Larsson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K083629

Confidential

12/5/2008

Regulation Number and Section

§ 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.