MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS

K102716 · Alma Lasers, Inc. · GEX · Sep 28, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K102716
• Device Name: MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS
• Applicant: Alma Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 28, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modified Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] includes a Diode Laser Module and an optional NIR Module. The Diode Laser Module: The HR Mode is intended for hair removal, permanent hair reduction. The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions. The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain. The Modified Alma Lasers Family of Soprano™ Diode Laser Systems [Soprano XL, Soprano XLi] is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Device Story

Multi-application platform utilizing diode laser and near-infrared (NIR) light technologies; console-based system with interchangeable handpieces and footswitch. Handpiece tip provides active, continuous skin cooling during application. Physician/clinician-operated; parameters controlled via LCD touch-screen interface connected to system micro-controller. Diode laser module delivers light pulses for hair removal and lesion treatment; NIR module provides topical heating for pain relief and increased local circulation. Output allows clinicians to perform dermatologic procedures; benefits include permanent hair reduction and temporary relief of musculoskeletal pain/stiffness.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Multi-application platform; diode laser and NIR light sources; active skin cooling handpiece; LCD touch-screen control panel; micro-controller based system; standalone console unit.

Indications for Use

Indicated for dermatologic and general surgical procedures, including hair removal, permanent hair reduction, treatment of benign vascular and pigmented lesions, and topical heating for relief of minor muscle/joint pain, stiffness, arthritis-related pain, muscle spasms, sprains, and strains. Suitable for all Fitzpatrick skin types I-VI, including tanned skin.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Soprano Hair Removal Diode Laser system (K052874)
• Alma Lasers Soprano XL Multi-Application Platform (K083848)
• Alma Lasers NIR Module (K080318)

Submission Summary (Full Text)

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2010 SEP 288

CONFIDENTIAL

# Appendix 7 - 510(k) Summary for Modified Alma Lasers Family of Soprano™ Diode Laser Systems [Soprano, Soprano XLi]

Summary Preparation Date: September 15, 2010

# · General Information

| Sponsor/<br>510(k) Owner | Sponsor | | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------------------|
| Address and<br>Establishment<br>Registration # | Alma Lasers, Inc.<br>485 Half Day Rd. Suite No. 100<br>Buffalo Grove, IL 60089, USA<br>FDA Registration #: 3004167969 | | |
| | Tatiana Epstein<br>VP QA&RA<br>Alma Lasers, Inc. | Telephone:<br>Facsimile:<br>Email: | (224 ) 377-2011<br>(224 ) 377-2050<br>[e-mail] |
| Contact Person: | Main Contact:<br>Tatiana Epstein<br>VP QA&RA<br>Alma Lasers, Inc. | Telephone:<br>Facsimile:<br>Email: | (224 ) 377-2011<br>(224 ) 377-2050<br>[e-mail] |
| | Secondary Contact:<br>Avi Farbstein<br>EVP and GM North America<br>Alma Lasers, Inc. | Telephone:<br>Facsimile:<br>Email: | (224 ) 377-2011<br>(224 ) 377-2050<br>[e-mail] |

· Names

| Device Names: | Modified Alma Lasers Family of Soprano XL™ Multi-<br>Application Platforms [Soprano XL, Soprano XLi] |
|-------------------------------|------------------------------------------------------------------------------------------------------|
| Primary Classification Names: | Laser Instrument, Surgical, Powered; GEX<br>Lamp, Infrared, Therapeutic Heating |

### · Predicate Devices

- Soprano Hair Removal Diode Laser system (K052874), cleared 11/22/2005, .
- . Alma Lasers Soprano XL Multi-Application Platform (K083848), cleared 04/14/2009
- Alma Lasers NIR Module (K080318), cleared 03/07/2008, .

# · Product Description

The Alma Lasers Soprano XLi system is a multi-application, multi-technology platform that supports the following technologies:

- · Diode laser technology
- · Near-infrared light technology (NIR) .

The Soprano XLi Diode Laser Module is intended for hair removal and long-term hair reduction, as well as for the treatment of benign vascular and pigmented lesions.

The Soprano XL system is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin.

The Soprano XLi NIR Module is indicated to elevate the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of

⁵ The Alma Lasers NIR Module is separately cleared under K080318.

Appendix 7: 510(k) Summary - Page 1 Special 510(k) Premarket Notification for: Alma Lasers Family of Soprano XL™ Multi-Application Platforms [Soprano XL, Soprano XLi]

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minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The complete Soprano XLi platform consists of its console, two available module handpieces and a footswitch (refer to Figure 1). The module is pressed against the patient's skin and a light pulse is delivered when the handpiece trigger and/or the footswitch are activated. The handpiece tip is cooled to provide active and continuous skin cooling.

Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen.

### · Indications for Use

The Modified Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] is intended for use in dermatologic and general surgical procedures.

The Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] includes a Diode Laser Module and an optional NIR Module.

The Diode Laser Module:

The HR Mode is intended for hair removal, permanent hair reduction.

The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions.

The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The Modified Alma Lasers Family of Soprano™ Diode Laser Systems [Soprano XL. Soprano XLi] is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

The intended use is identical to that previously cleared for the Soprano™ (K052874), Alma Lasers NIR Module (K080318) and Alma Lasers Soprano XL Multi-Application Platform (K083848).

The Indications for Use statement can be found in Appendix 4.

### · Rationale for Substantial Equivalence

The Modified Alma Lasers Family of Soprano XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] has the following similarities to the previously cleared Soprano™ Hair Removal Diode Laser System (K052874), Alma Lasers NIR Module (K080318) and Alma Lasers Soprano XL Multi-Application Platform (K083848):

- Has the same intended use and indications for use, ■
- Uses the same operating principle (technology), .
- " Incorporates the same basic design,
- Incorporates the same materials, ■
- Is packaged using the same materials and processes. .

In summary, the Modified Alma Lasers Family of Soprano™ XL™ Multi-Application Platforms [Soprano XL, Soprano Xli] is substantially equivalent to the predicate devices.

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# • Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Modified Alma Lasers Family of Soprano XLTM Multi-Application Platforms [Soprano XL, Soprano XLi] is substantially equivalent to the predicate devices.

### · Conclusion

Modified Alma Lasers Family of Soprano XLTM Multi-Application Platforms [Soprano XL, Soprano XLi] was found to be substantially equivalent to the predicate Soprano Family systems and devices.

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Image /page/3/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 left and has a small, curved beak. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

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

Alma Lasers, Inc. % Ms. Tatiana Epstein Vice President, QA & RA 485 Half Day Road, Suite 100 Buffalo Grove, Illinois 60089

SEP 2 8 2010

Re: K102716

Trade/Device Name: Modified Alma Lasers Family of Soprano XL." Multi-Application Platforms Regulation Number: 21 CFR 878.34810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 16, 2010 Received: September 21, 2010

Dear Ms. Epstein:

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.

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Page 2 - Ms. Tatiana Epstein

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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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510(k) Number (if known): K10

### Modified Alma Lasers Family of Soprano™ Multi-Application Platforms Device Name: [Soprano XL, Soprano XLi]

Indications for Use:

The Modified Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] is intended for use in dermatologic and general surgical procedures.

The Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XLi] includes a Diode Laser Module and an optional NIR Module.

The Diode Laser Module:

The HR Mode is intended for hair removal, permanent hair reduction. The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions.

The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The Modified Alma Lasers Family of Soprano™ Diode Laser Systems [Soprano XL, Soprano XLi] is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

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)

Nil RP Splem for mxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

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