TRANSCEND

K120510 · Syneron Medical, Ltd. · GEI · Jul 19, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K120510
• Device Name: TRANSCEND
• Applicant: Syneron Medical, Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Transcend is indicated for temporary reduction in circumference of the abdomen.

Device Story

Transcend System delivers optical energy (Infrared) and radio frequency (1 MHz) combined with vacuum to subcutaneous tissue; intended for temporary reduction in abdominal circumference. System comprises console with control panel, power supply, vacuum pump, Digital Signal Processor, and two applicators with LCD touch-screens. Operated by clinicians in a professional setting. Energy and vacuum application targets tissue to achieve circumference reduction. Healthcare providers monitor treatment via console interface. Benefits include non-invasive body contouring.

Clinical Evidence

Two prospective, multicenter clinical studies involving over 100 subjects evaluated abdomen circumference reduction. Primary endpoint: change in circumference from baseline at 1 week, 1 month, and 3 months post-treatment. Results demonstrated significant reduction in waist circumference compared to control. No serious adverse events reported. Bench testing included electromagnetic compatibility, electrical safety, and biocompatibility.

Technological Characteristics

System utilizes infrared optical energy and 1 MHz radio frequency combined with vacuum. Components include console, two applicators, and two LCD touch-screens. Includes vacuum pump and Digital Signal Processor. Software verification and validation performed. Sterilization method not specified.

Indications for Use

Indicated for temporary reduction in abdominal circumference in patients seeking cosmetic body contouring.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Syneron VelaShape system (K071872)
• Alma Lasers Accent UniForm Massager Handpiece (K082622)

Submission Summary (Full Text)

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## K 120510

## JUL 1 9 2013

#### 510(k) SUMMARY Syneron Medical Ltd's Transcend System

#### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Syneron Medical Ltd. Industrial zone Yokneam Illit 20692 Israel Tel: [phone] Fax: [phone]

Contact Person: Sam Wade, Global VP Regulatory Affairs

Contact details:

Tel: [phone] Ext. 330 Fax: [phone] E-mail: sam.wade(@candelalaser.com

Date Prepared: July 12, 2013

Name of Device Transcend System

#### Common or Usual Name

Laser surgical instrument for use in general and plastic surgery and in dermatology

#### Classification Name

NUV - Laser surgical instrument for use in general and plastic surgery and in dermatology GEI- Electrosurgical, Cutting & Coagulation & Accessories

#### Predicate Devices

Syneron VelaShape system (K071872) Alma Lasers Accent UniForm Massager Handpiece (K082622)

#### Intended Use / Indications for Use

The Transcend is indicated for temporary reduction in circumference of the abdomen.

### Technological Characteristics

The Syneron Transcend is an optical energy in the Infra Red range and a radio frequency of 1 MHz powered system. The device consists of a console and two applicators that deliver electromagnetic energy (IR light and Radio Frequency) and vacuum to treated

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tissue for the temporary reduction in circumference of the abdomen.

The Transcend console includes a control panel, power supply modules, vacuum pump, main Digital Signal Processor, umbilical cable and an adaptor- for connecting the two available applicators, two applicators and two LCD touch-screens.

#### Performance Data

The Transcend system performance was evaluated by lab tests and a supportive clinical Testing included electromagnetic compatibility, electrical safety, study. Lab Biocompatibility, and software verification and validation. All performance testing demonstrates that the Transcend System performs according to specifications and functions as intended. The Transcend fulfills the requirements for safety and efficacy.

The Transcend was evaluated in two prospective, multicenter studies for the intended use of abdomen circumference reduction, including over 100 subjects. Efficacy was evaluated based on the change in abdomen circumference from baseline to post treatment as evaluated at 1 week, 1 month, and 3 months following the last treatment session. Measurements were performed for both treated and control subjects. No serious adverse events related to the treatment were reported. The clinical study data for the Transcend subjects demonstrated significant reduction in waist circumference. The clinical data support the substantial equivalence of the Transcend system for the indication of temporary reduction in circumference of the abdomen. Additional data from clinical experience outside the United States further supports the performance of the Transcend for the intended use.

#### Substantial Equivalence

The Transcend is very similar to the VelaShape system and the Accent UniForm The Transcend has similar indications, technological Massager Handpiece. characteristics, and principles of operation as its predicate devices. Performance data demonstrate that the differences between the Transcend and the predicates do not adversely impact its performance. The efficacy of the Transcend was evaluated by a clinical trial to support the new indication for use.

Thus, the Transcend is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings. The emblem is rendered in a simple, bold design.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-002

July 19, 2013

Syneron Medical, Ltd. % Mr. Sam Wade Industrial Zone, Tavor Building P.O. Box 550 Yokneam Illit, Israel 20692

Re: K120510

Trade/Device Name: Transcend System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 17, 2013 Received: May 17, 2013

Dear Mr. Wade:

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 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

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Page 2 - Mr. Sam Wade

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K120510

Device Name: TRANSCEND

Indications For Use: The Transcend is indicated for temporary reduction in circumference of the abdomen

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(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)

Neil R Ogden 2013.07.12 14:07:54 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number_x120510

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