ACCENT

K070004 · Alma Lasers , Ltd. · GEI · Apr 23, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070004
• Device Name: ACCENT
• Applicant: Alma Lasers , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Accent™ device is intended for use in dermatologic and general surgical procedures. The Accent™ device is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids using combined treatment with UniPolar and BiPolar.

Device Story

Portable electrosurgical system delivering radiofrequency (RF) energy to treatment sites. Comprised of main console (RF module, power supply, cooling module) and UniPolar/BiPolar handpieces. Handpieces feature thermoelectric cooling (TEC) for patient comfort. Operated by clinicians in clinical settings. Device transforms electrical input into RF energy output; energy delivery controlled via handpiece trigger. Visual/audio indicators monitor emission. Output affects tissue via thermal effect, intended for wrinkle/rhytid reduction. Benefits include non-invasive aesthetic improvement.

Clinical Evidence

Clinical information provided to demonstrate safety and effectiveness for non-invasive treatment of wrinkles and rhytids. Specific study metrics, sample sizes, or statistical results not detailed in the provided summary text.

Technological Characteristics

Portable RF electrosurgical system. Components: main console, UniPolar/BiPolar handpieces with thermoelectric cooling (TEC). Energy source: RF. Connectivity: umbilical handpiece connection. Accessories: cart, water filling kit, non-contact thermometer.

Indications for Use

Indicated for non-invasive treatment of wrinkles and rhytids in patients undergoing dermatologic and 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

• Lumenis Aluma Skin Renewal System (K051214)
• Syneron Medical Polaris WR (K031671)
• Thermage ThermaCool TC (K053365, K040135, and K033942)
• Thermage ThermaCool IIA (K013034)

Submission Summary (Full Text)

{0}------------------------------------------------

K 07004

Page 1 of 2

# Section 5-510(k) Summary or 510(k) Statement

#### I. General Information

APR 2 3 2007

Submitter:

Alma Lasers, Ltd. Halamish Street (PO Box 3021), Industrial Park, Caesarea, 38900 ISRAEL

Contact Person:

Tatiana Epstein Regulatory Affairs Manager

Summary Preparation Date: April 20, 2007

### II. Names

Device Names:

Accent™

Electrosurgical, Cutting & Coagulation Device & Primary Classification Names: Accessories

### III. Predicate Devices

- Lumenis Aluma Skin Renewal System (K051214) .
- Syneron Medical Polaris WR (K031671) .
- Thermage ThermaCool TC (K053365, K040135, and K033942) t
- Thermage ThermaCool IIA (K013034) .

# IV. Product Description

The Alma Lasers Accent™ device is comprised of the following main components:

- Main console containing the major electrical components, including the: .
- Control Panel; A
- Radiofrequency (RF) Module; A
- a Power Supply Module;
- Service Panel; A
- A Cooling Module;
- A Handpiece holders;
- A Emergency stop push button;
- A Key switch;
- A RF energy emission visual and audio indicators;
- A Connector ports for the handpieces and power cord:
- A Main circuit breaker; and
- UniPolar (i.e., monopolar) and Bipolar Handpieces incorporating:
- Treatment tip with thermoelectric cooling (TEC) for cooling the treatment ア site during use for patient comfort;
- A Handpiece trigger;
- > Umbilical connection to the main console; and

{1}------------------------------------------------

K 070004

Page 2 of (2)

- Accessories:
- A Cart:
- Water Filling Kit;
- 0 Non-contact thermometer.

The Alma Lasers Accent™ is a portable system used to deliver radiofrequency energy to the patient treatment site via a delivery handpiece.

#### V. Indications for Use

The Accent™ device is intended for use in dermatologic and general surgical procedures.

The Accent™ device is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids using combined treatment with UniPolar and BiPolar.

## VI. Rationale for Substantial Equivalence

The Alma Lasers Accent™ device shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices. In addition, clinical information was provided to demonstrate safety and effectiveness.

# Safety and Effectiveness Information VII.

The review of the indications for use and technical characteristics and clinical information provided demonstrates that the Alma Lasers Accent™ device is substantially equivalent to the predicate devices. Clinical information demonstrating the safety and effectiveness of the Alma Lasers Accent™ device for the non-invasive treatment of wrinkles and rhytids was provided.

#### VIII. Conclusion

The Alma Lasers Accent™ device was found to be substantially equivalent to the predicate devices.

The Alma Lasers Accent™ device shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

{2}------------------------------------------------

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, resembling a caduceus or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alma Lasers, Ltd. % A. Worden Consulting Ms. Anne Worden Regulatory Consultant 3637 Bernal Avenue Pleasanton, California 94566

APR 2 3 2007

Re: K070004

Trade/Device Name: Accent™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 29, 2007 Received: April 2, 2007

Dear Ms. Worden:

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

{3}------------------------------------------------

Page 2 - Ms. Anne Worden

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

{4}------------------------------------------------

# Indications for Use Statement

510(k) Number (if known): K070004

Device Name: Accent™M

Indications for Use:

The Accent™ device is intended for use in dermatologic and general surgical procedures.

The Accent™ device is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids using combined treatment with UniPolar and BiPolar.


**(Division Sign-Off)**

Division of General, Restorative, and Neurological Devices

**510(k) Number** K070604

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)