The SMQQTHLIPO is the medical laser device using a diode laser module with emission of a beam of coherent light at 970nm ± 10 nm at a maximum power of 25W. The laser module consists of laser diodes assembled in series and optically aligned in order to focus in an optical fiber with the core of 600um. The optical fiber is connected to the laser module via a SMA 905 connector. The SMOOTHLIPO laser includes power supply for the laser (50A, 2V) and a Peltier element built on a ventilated radiator for efficient functioning of the device.

In addition, functional electronics is provided to allow for laser parameter setting and the safe functioning of the device. The adjustments of parameters is achieved through a TFT (touch) screen and a tactile flagstone.

AI/ML Overview

The provided text describes a 510(k) summary for the SMOOTHLIPO™ SYSTEM, a laser device intended for laser-assisted lipolysis. This summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical study to prove the device meets specific acceptance criteria based on performance. As such, much of the requested information about acceptance criteria, study details, and ground truth establishment is not present in the document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria for the SMOOTHLIPO™ system itself.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. No specific test set or clinical study data is presented for the SMOOTHLIPO™ system. The submission relies on the substantial equivalence to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. No test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set

This information is not provided. No test set is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This information is not provided. No MRMC study is mentioned.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This information is not applicable/not provided. The SMOOTHLIPO™ system is a physical laser device, not an algorithm, and the submission does not describe any standalone performance study.

7. The Type of Ground Truth Used

This information is not provided. As no clinical or performance study is detailed, no ground truth type is specified.

8. The Sample Size for the Training Set

This information is not provided. The device is a physical laser system, and the submission does not mention any "training set" in the context of an algorithm or AI.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. As there's no mention of a training set, there's no ground truth establishment for it.

Summary of the Device's Approach to Meeting Acceptance Criteria (as per the document):

The document indicates that the SMOOTHLIPO™ SYSTEM meets regulatory requirements and is accepted for marketing based on demonstrating substantial equivalence to a legally marketed predicate device, the PHARAON LIPO by OSYRIS INC. (K073617).

The key points regarding this approach are:

Conformance to Guidance: The SMOOTHLIPO™ conforms to "Guidance on the content and organization of a premarket notification for a medical laser (June 1995)" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)." It also conforms to 21CFR part 1040.10 and 1040.11.
Substantial Equivalence: The primary basis for acceptance is that the SMOOTHLIPO™ has the "same intended use, material design and function as predicate device PHARAON LIPO (K073617)."
Identical Manufacturing and Performance (asserted): The submission explicitly states, "In essence, the SMOOTHLIPO which is manufactured by Osyris is identical to PHARAON LIPO 980 laser from Osyris in its manufacturing, performance, and indications." This implies that because it is identical to a device already deemed safe and effective, it inherently meets the necessary "acceptance criteria" through that equivalence.

Therefore, the "study" that proves the device meets acceptance criteria, in this context, is the Premarket Notification (510(k)) submission process itself, which successfully demonstrated substantial equivalence to a predicate device, rather than a specific clinical trial or performance study detailed within this summary.

Summary

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K083478

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS MAR 1 7 2009

As required by section 807.92(c)

5 -1 GENERAL INFORMATION

Trade Name	SMOOTHLIPO™ SYSTEM
Classification Name	LASER INSTRUMENT, SURGICAL, POWERED
Class	II
Product Code	GEX
CFR section	878.4810
Device panel	General & Plastic Surgery
Legally marketedpredicate devices	K073617: PHARAON LIPO by OSYRIS INC.
Submitter	Elemé Medical, Inc.Heron Cove Office Part10 Al Paul Lane, Suite 102Merrimack, NH 03054
Contacts	Michail M. Pankratov, Vice President, Clinical & Regulatory Affairsmpankratov@elememedical.comPhone: 1-603-816-1645Fax: 1-603-662-4762

5 -2. DEVICE DESCRIPTION

5 - 3. INTENDED USE

SMOOTHLIPO is intended for laser-assisted lipolysis

5 - 4. PERFORMANCE DATA

SMOOTHLIPO conforms to Guidance on the content and organization of a premarket notification for a medical laser (June 1995) and to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).

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K083476 Pg2 of 2

SMOOTHLIPO conforms to 21CFR part 1040.10 and 1040.11.

5 - 5. SUBSTANTIAL EQUIVALENCE

SMOOTHLIPO has the same intended use, material design and function as predicate device PHARAON LIPO (K073617).

In essence, the SMOOTHLIPO which is manufactured by Osyris is identical to PHARAON LIPO 980 laser from Osyris in its manufacturing, performance, and indications.

Summary preparation date: 11/20/08

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.

MAR 1 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elemé Medical, Inc. % Michail M. Pankratov, MD, PhD VP, Clinical and Regulatory Affairs Heron Cove Office Park 10 Al Paul Lane, Suite 102 Merrimack, New Hampshire 03054

Re: K083478

Trade/Device Name: SMOOTHLIP" 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: GEX Dated: March 5, 2009 Received: March 6, 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, 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

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·Page 2 - Michail M. 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). For 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.

for A. in for.

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

Enclosure

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K08347-8

INDICATIONS FOR USE

510(k) Number (if known): KBOWN 194

Device Name: SMOOTHLIPO™ System

Indications for Use: The SMOOTHLIPO is intended for laser-assisted lipolysis

Prescription Use く (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)

Neil R.Oehl forman

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

510(k) Number K083478

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.