VENUS SWAN SYSTEM

K111784 · Venus Concept , Ltd. · GEI · Oct 7, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111784
• Device Name: VENUS SWAN SYSTEM
• Applicant: Venus Concept , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Venus Swan is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

Device Story

Non-invasive RF system for facial wrinkle treatment; utilizes (MP)2 technology (Multi-Polar array of Bi-Polar RF electrodes). System comprises main console, touch screen interface, RF power module, and controller. Three interchangeable applicators (Octipolar-LTM, Octipolar-M, Diamondpolar) provide 1MHz RF energy to skin. Operated by clinicians in dermatologic/surgical settings. User selects applicator based on treatment area size and adjusts RF power/time via interface. RF energy delivery targets tissue to address rhytides. Benefits include non-invasive aesthetic improvement.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing and adherence to recognized electrical safety and electromagnetic compatibility standards.

Technological Characteristics

Multi-Polar RF energy delivery (1MHz signal). System includes console, touch screen, and three applicators (4 or 8 electrodes). Complies with EN 60601-1 (safety), IEC 60601-1-2 (EMC), and ANSI AAMI 60601-2-2 (high-frequency surgical equipment).

Indications for Use

Indicated for the non-invasive treatment of mild to moderate facial wrinkles and rhytides in patients undergoing dermatologic or general surgical procedures.

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

• Venus Freeze (K100586)

Submission Summary (Full Text)

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OCT - 7 2011

# Venuscollicept

#### 510(K) SUMMARY

## Venus Swan™ System 510(k) Number K | 784

Applicant's Name: Venus Concept Ltd. 62 HaHermesh Street Karmiel, 21652, Israel Tel: [phone] Fax: [phone]

Yoram Levy, Qsite Contact Person: 31 Haavoda St. Binyamina, Israel 30500 Tel [phone]; Fax [phone] [e-mail]

Venus Swan™M Trade Name:

Preparation Date: June 20, 2011

Classification: Name: Electrosurgical, cutting & coagulation device & accessories Product Code: GEI Regulation No: 21 CFR 878.4400 Class: II Panel: General and Plastic Surgery

#### Device Description:

The Venus Swan™ System uses Radiofrequency (RF) energy in (MP)2 technology for treatment. (MP)2 technology is a Multi-Polar array of Bi-Polar RF electrodes.

The Venus Swan™ is a modification to the previously cleared Venus Concept's Venus Freeze system (K100586).

The Venus Swan™ is a non-invasive system consisting of:

- Main Unit (console) -
- Touch Screen user interface -
- RF Power module
- Controller unit

Venus Swan - Special 510k Submission

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# VENUSCOUCEP

Controller unit

Three optional treatment applicators:

(1) Octipolar-LTM applicator - for large treatment areas, composed of 8 RF electrodes

(2) Octipolar-M™ applicator - for medium sized treatment areas, composed of 8 RF electrodes

(3) Diamondpolar™ applicator - for small treatment areas, composed of 4 RF electrodes

The system can be connected to two applicators only at a time. The user can choose which applicator to use according to the size of the treatment area.

The Touch screen user interface provides:

- Applicator selection -
- RF Power Output and Treatment Time parameter adjustments -
- Current treatment parameters display.

Controller unit

Three optional treatment applicators

The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

#### Intended Use Statement:

The Venus Swan is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

Substantial equivalence to the following predicate device is claimed: Predicate Devices:

| Device Name | 510k No. | Date of Clearance |
|--------------|----------|-------------------|
| Venus Freeze | K100586 | Nov 29, 2010 |

#### Performance Standards

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: 1 : 1 : 1 :

Venus Swan complies with the following voluntary standards:

- EN 60601-1 (Medical Electrical Equipment-Part 1: General . Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).
- IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: Collateral . Standard: Electromagnetic Compatibility - Requirements and Tests)
- ANSI AAMI 60601-2-2 for safety of high frequency surgical equipment.

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#### Venus Swan - Special 510k Submission

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002

Venus Concept Ltd. % Qsite Mr. Yoram Levy 31 Haavoda Street Binyamina, Israel 30500

- 7 2011

Re: K111784

Trade/Device Name: Venus Swan™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 22, 2011 Received: September 06, 2011

Dear Mr. Levy:

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. Yoram Levy

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 331-542 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.hum 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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## Venuscollicept

### INDICATIONS FOR USE STATEMENT

× 111784 510(k) Number (if known):

Device Name:

Venus Swan

Indications for Use:

The Venus Swan™ is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

Prescription Use X (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)

(Division Sign-off) Division of General, Restorative and Neurological Devices 510(k) Number

NufRP&d for mkm
(Division Sign-Off)

iston Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111784

Venus Swan .- Special 510k Submission

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