ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL

K072699 · Alma Lasers , Ltd. · GEI · Oct 5, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072699
• Device Name: ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL
• Applicant: Alma Lasers , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alma Lasers Family of Accent™ RF Systems [Accent XL] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces.

Device Story

The Alma Lasers Family of Accent™ RF Systems (Accent, Accent XL) is an electrosurgical device used in dermatologic and general surgical procedures. The system consists of a console, control panel, footswitch, and various RF handpieces (Bipolar normal/small-tip and Unipolar normal/unilarge). The device delivers radiofrequency (RF) energy to tissue to treat wrinkles and rhytids. It is operated by a clinician in a clinical setting. The system utilizes both Bipolar and Unipolar RF modalities, which can be used in combination to achieve the intended therapeutic effect on the skin.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Electrosurgical cutting and coagulation device. System components include a console, control panel, footswitch, and Bipolar/Unipolar RF handpieces. Energy source is radiofrequency. Device is intended for dermatologic and general surgical use.

Indications for Use

Indicated for the 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

• Accent™ (K070004)

Submission Summary (Full Text)

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CONFIDENTIAL

### Appendix 7 - 510(k) Summary for the Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL]

#### I. General Information

| Submitter: | Alma Lasers, Ltd.<br>Halamish Street (PO Box 3021), Industrial Park,<br>Caesarea, 38900<br>ISRAEL |
|-----------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Tatiana Epstein<br>Regulatory Affairs Manager,<br>Alma Lasers, Ltd. |
| | Anne Worden |

Regulatory Consultant to Alma Lasers, Ltd.

Summary Preparation Date: September 19, 2007

- II. Names
Device Names:

Alma Lasers Family of Accent™ RF Systems

Primary Classification Names:

Electrosurgical cutting and coagulation device and accessories

#### III. Predicate Devices

- Alma Lasers, Ltd. Accent™ (K070004) .
#### IV. Product Description

The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is comprised of the following main components:

- Console .
- A Bipolar RF handpieces (normal and small-tip)
- A Unipolar RF handpieces (normal and unilarge)
- Control panel .
- Footswitch. .

#### V. Indications for Use

The Alma Lasers Family of Accent™ RF Systems is intended for use in dermatologic and general surgical procedures.

The Indications for Use of the Accent™ RF Systems are provided in Appendix 4.

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#### VI. Rationale for Substantial Equivalence

The Alma Lasers Accent XL™ RF device shares the same indications for use, device operation, technical and functional capabilities, and therefore is substantially equivalent to the predicate Accent™ system.

#### VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Accent XL™ RF device is substantially equivalent to the predicate Accent™ system.

#### VIII. Conclusion

The Accent XL™ RF device was found to be substantially equivalent to the predicate Accent™ system.

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

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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 stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

0CT 5 * 2007

Re: K072699

Trade/Device Name: Alma Lasers Family of Accent" RF Systems Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 19, 2007 Received: September 24, 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

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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 A. Millican

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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# Page 3 – Ms. Anne Worden

cc: HF7-401 DMC HFZ-404 510(k) Staff HFZ-410 (DGRND/GSDB) D.O. f/t:GJM:kxl:10-01-07

## OC Numbers:

. . . . . .

| Division of Enforcement A | 240-276-0115 |
|-----------------------------------------------------------|--------------|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |

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510(k) Number (if known): ____K072 699

Device Name: The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL]

Indications for Use:

The Alma Lasers Family of Accent™ RF Systems [Accent XL] is intended for use in dermatologic and general surgical procedures.

The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is indicated for the non-The Alma Baser Painty of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces.

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)

Mark H Millikin

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

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510(k) Number