Accent XL

K160075 · Alma Lasers, Inc. · IMI · Aug 17, 2016 · Physical Medicine

Device Facts

• Record ID: K160075
• Device Name: Accent XL
• Applicant: Alma Lasers, Inc.
• Product Code: IMI · Physical Medicine
• Decision Date: Aug 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Modified Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures. The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces. The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide: -Temporary reduction in the appearance of cellulite. Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide: -Temporary reduction in the appearance of cellulite. The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids. The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin. Ultrasound Module provides ultrasonic diathermy intended for: - Relief of pain - Muscle spasms - Joint contractures - NOT for the treatment of malignancies

Device Story

Accent XL is a multi-modality console supporting previously cleared RF/massage handpieces and a new therapeutic ultrasound handpiece. Ultrasound module converts electromagnetic energy into 1 MHz ultrasonic oscillations to deliver deep therapeutic heat. Used in clinical settings by trained operators. Console features LCD touch screen for treatment selection and output monitoring. Ultrasound output parameters (intensity, duration) are controlled to maintain skin temperature at 40-45°C for therapeutic relief of pain, muscle spasms, and joint contractures. Benefits include non-invasive treatment options for dermatological conditions and musculoskeletal pain relief.

Clinical Evidence

Bench testing only. Testing verified compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-2 (HF surgical equipment), and IEC 60601-2-5 (ultrasonic physiotherapy). Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10. Performance bench testing confirmed the ultrasound module's ability to raise and maintain skin temperature at 40-45°C for 10-30 minutes without adverse effects.

Technological Characteristics

Console-based system with 1 MHz ultrasound handpiece (1.2 cm2 ERA, 6:1 BNR, 3W/cm2 intensity). RF components operate at 40.68 MHz. Materials include anodized aluminum and Delrin plastic. Features thermoelectric cooling. Connectivity via console interface. Software-controlled output. Sterilization: Reusable/serializable tips and disposable options.

Indications for Use

Indicated for dermatological and general surgical procedures, including non-invasive treatment of wrinkles and rhytids (via Unipolar/Bipolar RF), temporary reduction in cellulite appearance (via RF/massage), and skin ablation/resurfacing (via Pixel RF). Ultrasound module indicated for relief of pain, muscle spasms, and joint contractures. Contraindicated for treatment of malignancies.

Regulatory Classification

Identification

An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Predicate Devices

• General Project MC1 (K091615)

Reference Devices

• Zimmer Sono 5 (K952536)
• Alma Lasers Family of Pixel RF Tips (K121150)
• Modified Alma Lasers Family of Accent Radiofrequency (RF) System (K101147)
• Alma Lasers Accent B-Shape Massager Hand piece/Module (K082622)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

August 17, 2016

Alma Lasers Inc. % Kathy Maynor Consultant Kathy Maynor 26 Rebecca Ct Homosassa, Florida 34446

Re: K160075

Trade/Device Name: Accent XL Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: Class II Product Code: IMI, GEI; ISA; NUV Dated: July 15, 2016 Received: July 20, 2016

Dear Ms. Maynor:

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 device

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

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 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J.Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known) K160075

Device Name Accent XL

## Indications for Use (Describe)

The Modified Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures.

The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces.

The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:

-Temporary reduction in the appearance of cellulite.

Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:

-Temporary reduction in the appearance of cellulite.

The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.

The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

Ultrasound Module provides ultrasonic diathermy intended for:

- Relief of pain
- Muscle spasms
- · Joint contractures
- · NOT for the treatment of malignancies

The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# K160075 510(k) Summary

#### I. General Information

II.

| 510(k) Holder: | Alma Lasers Inc.<br>485 Half Day Rd. Suite 100<br>Buffalo Grove, IL 60089 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathy Maynor<br>Regulatory Consultant<br>352-586-3113 |
| Summary Preparation Date: | August 16, 2016 |
| Names | |
| Trade Name: | Accent XL |
| Classification Names: | Diathermy, Ultrasonic,<br>For Use in Applying<br>Deep<br>Therapeutic Heat<br>Electrosurgical Cutting Devices and Accessories<br>Therapeutic Massager |
| Product Codes: | IMI (Primary) – Diathermy, Ultrasonic, For Use in<br>Applying Deep Therapeutic Heat<br>GEI- Electrosurgical, Cutting & Coagulation &<br>Accessories<br>ISA - Massager, Therapeutic, Electric<br>NUV - Massager, Vacuum, Light Induced Heating |
| Classification Panels: | Physical Medicine for ultrasound hand piece<br>General and Plastic Surgery for other hand pieces |
| Regulations: | 21 CFR Part 890.5300 Ultrasonic Diathermy<br>21 CFR Part 878.4400 Electrosurgical Cutting Devices<br>21 CFR 890.5660 Therapeutic Massager<br>21 CFR 878.4810 Laser Surgical Instrument For Use In<br>General and Plastic Surgery and in Dermatology |
| Common Name: | Ultrasound, Surgical Devices, Radiofrequency |

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

#### III. Predicate Devices

| K091615 | General Project MC1 (primary) |
|---------|------------------------------------------------------------------|
| K952536 | Zimmer Sono 5 (reference) |
| K121150 | Alma Lasers Family of Pixel RF Tips |
| K101147 | Modified Alma Lasers Family of Accent Radiofrequency (RF) System |
| K082622 | Alma Lasers Accent B-Shape Massager Hand piece/Module |

#### IV. Product Description

The Alma Lasers Accent XL is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

#### V. Indications for Use

The Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures.

The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces.

The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:

- . Temporary reduction in the appearance of cellulite.
Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL. Accent Elite] to provide:

- Temporary reduction in the appearance of cellulite.
The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.

The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

Ultrasound Module provides ultrasonic diathermy intended for: · Relief of pain

Premarket Notification, Traditional 510(k)

{5}------------------------------------------------

- Muscle spasms
- Joint contractures
- NOT for the treatment of malignancies

The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].

{6}------------------------------------------------

#### Summary of Technical Characteristics VI.

# Ultrasound

| Parameter | K160075<br>Accent XL with the Alma Ultra<br>handpiece | K091615<br>MC1 General Project | K952536<br>Zimmer Sono 5 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Product Code & Regulation No. | IMI<br>21 CFR 890.5300 | IMI<br>21 CFR 890.5300 | IMI<br>21 CFR 890.5300 |
| Cooling | Thermoelectric | Unk, | Unk. |
| Ultrasounds Frequency | 1MHz (± 20%) | 1MHz (± 20%) | 0.8MHz |
| Pulse Modulation Frequency | Continuous | Pulsed 20-60kHz | Continuous |
| Effective Radiating Area (ERA) | 1.2 cm2 | 4.9cm2 | 5.0cm2 |
| BNR (Maximum Beam Non-<br>uniformity Ratio) | 6:1 | 4:1 | 6:1 |
| Ultrasonic Intensity | 3W/cm2 | 3W/cm2 | 3W/cm2 |
| Max treatment time | 30 minutes | 30 minutes | 30 minutes |
| User Interface | LCD touch screen | LCD touch screen | Unk. |
| Electrical Requirements | 100-240VAC,<br>50-60 Hz,<br>6.3 A, | 100-240VAC<br>50-60 Hz | Unk. |
| Indications for Use | Ultrasonic Diathermy:<br>1. Relief of pain;<br>2. Muscle spasms;<br>3. Joint contractures;<br>4. NOT for the treatment of malignancies. | Ultrasonic Diathermy:<br>1. Relief of pain;<br>2. Muscle spasms;<br>3. Joint contractures;<br>4. NOT for the treatment of<br>malignancies. | Not available in FDA<br>website database |

{7}------------------------------------------------

# RF and Massage

| Device Name | K160075 | K121150 | K101147 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Accent XL with the Alma Ultra Hand piece | Alma Lasers, Ltd.<br>Family of Accent RF Pixel Tips with PixelRF<br>Module/ Hand piece | Alma Lasers Family of Accent RF Systems<br>[Accent, Accent XL, Accent Elite] (w/ UniPolar &<br>BiPolar Hand pieces] |
| Product Code | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery |
| Regulation | • GEI, OUH, NUV, ISA - 21 CFR 878.4400 | • GEI, OUH - 21 CFR 878.4400 | • NUV, GEI, ISA - 21 CFR 878.4810 |
| Intended Use | Intended for use in dermatologic and general | Intended for use in dermatologic and general | Intended for use in dermatologic and general |
| | surgical procedures | surgical procedures | surgical procedures |
| Indications for Use | The Unipolar and Bipolar hand pieces, when<br>used as a combined treatment, are indicated for<br>the non-invasive treatment of wrinkles and<br>rhytids.<br>The Pixel RF Tips (stationary and rolling), when<br>used with the unipolar hand piece, are indicated<br>for dermatological procedures requiring<br>ablation and resurfacing of the skin. | The Alma Lasers family of Accent RF Systems<br>(Accent, Accent XL, Accent Elite) with Unipolar<br>and Bipolar Hand pieces are intended for use in<br>dermatologic and general surgical procedures.<br>The Unipolar and Bipolar hand pieces, when used<br>as a combined treatment, are indicated for the<br>non-invasive treatment of wrinkles and rhytids.<br>The Pixel RF Tips (stationary and rolling), when<br>used with the unipolar hand piece, are indicated<br>for dermatological procedures requiring ablation<br>and resurfacing of the skin. | Indicated for: The non-invasive treatment of<br>wrinkles and rhytids using a combined treatment<br>with Unipolar and Bipolar hand pieces |
| RF Power<br>(or Energy) | • UniPolar & UniLarge<br>Up to 200 W (1.51 W/mm2)<br>• BiPolar & BiPolarS<br>Up to 420 W (1.51 W/mm2) | • UniPolar<br>Up to 200 W (2.08 W/mm2) | • UniPolar & UniLarge<br>Up to 200 W (1.51 W/mm2)<br>• BiPolar & BiPolarS<br>Up to 420 W (1.51 W/mm2) |
| Peak Output | 300W | 300W | 300W |
| RF Frequency | $40.68 MHz \pm 20 kHz$ | 40.680MHz | 40.680MHz |
| Device Name<br>Characteristics | K160075<br>Accent XL with the Alma Ultra Hand piece | K121150<br>Alma Lasers, Ltd.<br>Family of Accent RF PixelRF Tips with PixelRF<br>Module/ Hand piece | K101147<br>Alma Lasers Family of Accent RF Systems<br>[Accent, Accent XL, Accent Elite] (w/ UniPolar &<br>BiPolar Hand pieces] |
| Pulse modulation<br>frequency | RF Pixel:<br>65KHz<br>UniPolar & BiPolar Hand pieces:<br>15KHz | RF Pixel:<br>65KHz | UniPolar & BiPolar Hand pieces:<br>15KHz |
| Pulse modulation<br>control | PWM | PWM | PWM |
| Standing Wave Ratio | 1:2 | 1:2 | 1:2 |
| RF massage ring<br>rotation speed | 150 turns/min (tpm) | Not applicable | 150 turns/min (tpm) |
| Handpiece-Patient<br>contact interface area | • UniPolar & UniLarge<br>13 to 19 mm dia.<br>• BiPolarS & BiPolar<br>8.95 to 13 mm dia.<br>• Stationary PixelRF Tips (Unipolar)<br>12 mm dia.<br>• Roller PixelRF Tips (Unipolar)<br>10 x 22.7 mm circumference 'roller' | • Stationary PixelRF Tips (Unipolar)<br>12 mm dia.<br>• Roller PixelRF Tips (Unipolar)<br>10 x 22.7 mm circumference 'roller' | • UniPolar & UniLarge<br>13 to 19 mm dia.<br>• BiPolarS & BiPolar<br>8.95 to 13 mm dia. |
| Tip Matrix | Stationary PixelRF Tips<br>• ~ 110 Pixel points (1.0 pixels/mm2)<br>Roller PixelRF Tips<br>• ~132 Pixel points per cm (1.3 pixels/mm2) | Stationary PixelRF Tips<br>• ~ 110 Pixel points (1.0 pixels/mm2)<br>Roller PixelRF Tips<br>• ~132 Pixel points per cm (1.3 pixels/mm2) | Not applicable |
| Tip Matrix type | Electrodes | Electrodes | Not applicable |
| Cooling | Thermo-electric cooling | Not applicable | Thermo-electric cooling |
| Device Name<br>Characteristics | K160075<br>Accent XL with the Alma Ultra Hand piece | K121150<br>Alma Lasers, Ltd.<br>Family of Accent RF Pixel Tips with PixelRF<br>Module/ Hand piece | K101147<br>Alma Lasers Family of Accent RF Systems<br>[Accent, Accent XL, Accent Elite] (w/ UniPolar &<br>BiPolar Hand pieces] |
| Handpiece<br>Size/Weight<br>Dimensions | Size:<br>• UniPolar - 169 x 205 mm<br>• BiPolar - 167 x 203 mm<br>• PixelRF Hand piece - 160 x 155 mm<br>Weight: | Size:<br>PixelRF Hand piece - 160 x 155 mm<br>Weight: | Size:<br>• UniPolar - 169 x 205 mm<br>• BiPolar - 167 x 203 mm<br>Weight: |
| Patient Contact<br>Materials | Hand pieces:<br>• Anodized aluminum and Delrin plastic<br>Tip:<br>• Stationary PixelRF Tips – Aluminum<br>• Roller PixelRF Tips – Aluminum, Sapphire | • Stationary PixelRF Tips – Aluminum<br>• Roller PixelRF Tips – Aluminum, Sapphire | Hand pieces:<br>• Anodized aluminum and Delrin plastic |
| How provided | Disposable and Reusable Stationary & Roller<br>PixelRF Tips:<br>Reusable, cleanable, serializable Tips and<br>disposable tips also available | Disposable and Reusable Stationary & Roller<br>PixelRF Tips:<br>• Reusable, cleanable, serializable Tips and<br>disposable tips also available | Not applicable |

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

#### VII. Substantial Equivalence Information and Performance Testing

The review of the indications for use and technical characteristics provided above, demonstrates that the Accent XL with the Alma Ultra hand piece, is substantially equivalent to the predicate devices.

Testing was performed in accordance with the following IEC tests:

IEC 60601-1:05+CORR.1(2006)+CORR.2(2007)+A1:12 The general standard IEC 60601-1 - Medical Equipment / medical electrical equipment - Part 1: General requirements for basic safety and essential performance - gives general requirements of the series of standards. The standard contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment.

IEC 60601-1-2:2007 (edition 3.0): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

IEC 60601-2-2:2009: Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC 60601-2-5:2009: Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment.

Biocompatibility testing was performed in accordance with the following standards and the patient contacting material for the ultrasound hand piece has been previously cleared in K042000 and K141237:

ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:1999 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

# Performance Bench Testing

Additionally, temperature testing was conducted to ensure that (1) the ultrasound device must raise the skin temperature to 40-45°C in less than 15 minutes, (2) the ultrasound device must be capable of maintaining the skin temperature at 40-45°C for a minimum of 10 minutes and (3) the ultrasound device can treat for 30 minutes with no adverse effects.

#### Conclusion VIII.

The Accent XL with the Alma Ultra hand piece has the same intended use as the predicate devices with similar indications for use. It presents similar technological

{11}------------------------------------------------

characteristics as the predicate device including design features, ultrasonic intensity, ultrasound frequency etc.

Although there are some differences between the Accent XL with the Alma Ultrasound hand piece, and its predicate devices in terms of Effective Radiating Area (ERA), BNR (Maximum Beam Non-uniformity Ratio) etc., the differences do not present any new concerns of safety and effectiveness, since the Accent XL with the Alma Ultra hand piece parameters are within the range used by the predicate devices for treatment of temporary relief of pain, muscle spasms and joint contractures.

The Accent XL with the Alma Ultra hand piece and its predicate devices operate with the same mechanism of action, based on converting electromagnetic energy in ultrasonic oscillations and delivering ultrasonic waves to the treated area.

The RF hand pieces and the massager hand piece that can also be attached to the Accent XL console were previously cleared via K121150 and K101147.

Therefore, the Accent XL with the Alma Ultra hand piece has the same intended use, technological characteristics, and principles of operation as the predicate devices. Thus, the Accent XL with the Alma Ultra hand piece is substantially equivalent to the predicate device.