ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION

K112031 · Alma Lasers, Inc. · GEX · Sep 13, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K112031
• Device Name: ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
• Applicant: Alma Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 13, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use in dermatologic and general surgical procedures. The Alma Lasers Modified Diode Laser Module (used with the Alma Lasers Family of Soprano XL Multi-Application Platforms): - The HR Mode is intended for hair removal, permanent hair reduction. - The SHR Mode is intended for hair removal, permanent hair reduction. - The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions. The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Device Story

Diode laser module for use with Soprano XL multi-application platforms; delivers 810 nm laser energy via handpiece. Components include module housing, trigger switch, TEC-cooled light guide, and umbilical cable. Operates in HR, SHR, and LaserBlanche modes. SHR mode utilizes low fluence, high repetition rate (up to 10 Hz), and multiple-pass regimen for hair removal. Physician-operated in clinical settings. Laser energy targets hair follicles or vascular/pigmented lesions. Cooling system protects skin during treatment. Output allows for permanent hair reduction and lesion treatment; benefits include effective hair removal across all skin types.

Clinical Evidence

Clinical evidence based on published peer-reviewed literature involving 2,879 patients. Studies evaluated safety and performance of the 810 nm Diode Laser Module and SHR mode for hair removal and permanent hair reduction. Follow-up assessments conducted immediately, 1, 6, and 18 months post-treatment. Results supported the safety and effectiveness of the low fluence, high repetition rate, multiple-pass treatment regimen.

Technological Characteristics

810 nm diode laser module; TEC-cooled light guide for contact skin cooling. Repetition rate up to 10 Hz; fluence ≤ 10 J/cm2 (SHR mode). Connects to Soprano XL system console via umbilical cable. Class II device.

Indications for Use

Indicated for hair removal, permanent hair reduction, and treatment of benign vascular and pigmented lesions in patients of all skin types (Fitzpatrick 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

• Modified Alma Lasers Family of Soprano Multi-Application Platforms [Soprano XLTM, Soprano XLi™] (K102716)
• Alma Lasers Soprano XL Multi-Application Platform (K083848)

Submission Summary (Full Text)

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K112031

Appendix G - 510(k) Summary for the Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms

#### I. 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 | | |
| Contact<br>Person: | Tatiana Epstein<br>VP QA&RA<br>Alma Lasers, Inc. | Telephone: [phone]<br>Facsimile: [phone]<br>Email: [e-mail] | |

September 13, 2011 Summary Preparation Date:

#### II. Names

Device Names:

Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms

| Primary Classification | |
|------------------------|----------------------------------------------------------------------------------------|
| Names: | Laser Powered Surgical Instruments (and accessories) |
| Regulation Number: | 21 CFR 878.4810 |
| Regulation Name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology |
| Regulatory Class: | Class II |
| Product Code: | GEX |

### III. Predicate Devices

- Modified Alma Lasers Family of Soprano Multi-Application Platforms [Soprano � XLTM, Soprano XLi™] (K102716)
- Alma Lasers Soprano XL Multi-Application Platform (K083848) .

### IV. Product Description

The Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms, and the delivery accessories that are used with it, is comprised of the following main components:

- A module housing with: .
- Module trigger switch (must be pressed at the same time the Soprano system A footswitch is depressed to deliver laser energy to the treatment site);
- A Light guide
- TEC-cooled to provide contact skin cooling 9
- A Light guide retainer
- Umbilical cable and connector that attaches the Diode Laser Module to the Soprano . system console and includes the electrical and cooling connections to the Soprano system.

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#### V. Indications for Use

The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use in dermatologic and general surgical procedures.

The Alma Lasers Modified Diode Laser Module (used with the Alma Lasers Family of Soprano XL Multi-Application Platforms):

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

The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

#### VI. Rationale for Substantial Equivalence

The Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms shares the same indications for use, device operation, technical and functional capabilities, and therefore is substantially equivalent to the predicate Modified Alma Lasers Family of Soprano Multi-Application Platforms [Soprano XLTM, Soprano XLi™] (K102716) and the Alma Lasers Soprano XL Multi-Application Platform (K083848).

| Parameter | K11<br>Alma Lasers Modified Diode Laser Module<br>with SHR Treatment Mode used with the<br>Soprano XL Multi-Application Platforms | | | K102716<br>Modified Alma Lasers Family of<br>Soprano Multi-Application<br>Platforms [Soprano XLTM,<br>Soprano XLiTM] | | K083848<br>Alma Lasers<br>Soprano XL Multi-<br>Application<br>Platform | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------|--|
| Diode<br>Module<br>Mode | SHR Mode | HR Mode | LB Mode | HR Mode | LB Mode | HR Mode | |
| Laser<br>Wavelength | 810 nm (nominal) | | | 810 nm (nominal) | | 810 nm (nominal) | |
| Indications<br>for Use | Intended for hair removal,<br>permanent hair reduction | | Intended for<br>treatment of<br>benign vascular<br>and pigmented<br>lesions | Intended for hair<br>removal,<br>permanent hair<br>reduction | Intended for<br>treatment of<br>benign vascular<br>and pigmented<br>lesions | Intended for hair<br>removal, permanent<br>hair reduction | |
| Soprano<br>System<br>Indications<br>for Use | • Intended for use in dermatologic and general surgical procedures<br>• Intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. | | | | | | |
| Spot Size | 1.2 cm2 | | | 1.2 cm2 | | 1.2 cm2 | |
| Fluence<br>(Energy<br>Density) | ≤ 10 J/cm2 | ≤ 120 J/cm2 | ≤ 80 J/cm2 | ≤ 120 J/cm2 | ≤ 80 J/cm2 | ≤ 120 J/cm2 | |
| Rep Rate | ≤ 10 Hz | ≤ 3 Hz | | ≤ 3 Hz | | ≤ 3 Hz | |
| Pulse<br>Duration | ≤ 20 ms | 5-200 ms | | 5-200 ms | | 5-200 ms | |
| Compatible<br>Laser Syst. | Used with Family of Soprano XL Multi-<br>Application Platforms | | | Family of Soprano XL Multi-<br>Application Platforms | | Soprano XL System | |

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#### VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms is substantially equivalent to the predicate Modified Alma Lasers Family of Soprano Multi-Application Platforms [Soprano XL™] Soprano XLi™] (K102716) and the Alma Lasers Soprano XL Multi-Application Platform (K083848).

In addition, published peer-reviewed medical literature provided device validation information demonstrating that the changes do not raise new questions of safety or effectiveness.

The supporting published information reported on clinical studies in 2,879 patients demonstrating the safety and effectiveness/performance of the 810 nm Diode Laser Module handpiece and the SHR Treatment Mode (used with the Soprano system console) for hair removal and permanent hair reduction.

These studies reported on the safety and effectiveness/performance immediately following treatment and at 1, 6, and 18 months following treatment with the 810 nm Diode Laser Module handpiece and the SHR treatment Mode (used with the Soprano system console) using the low fluence, high repetition rate, multiple-pass treatment regimen.

#### VIII. Conclusion

The Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms was found to be substantially equivalent to the predicate devices.

The Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is smaller than the central image.

## Public Flealth Service

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

Alma Lasers, Inc. % A. Worden Consulting Ms. Anne Worden 485 Half Day Road. Suite 100 Buffalo Grove, Illinois 60089

1 3 2511

Re: K112031

Trade/Device Name: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platform Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: July 13, 2011

Received: July 15, 2011

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. 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. Anne Worden

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 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/ucm115809.html 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 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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pg 1 of 1

K11203 1 510(k) Number (if known):

## Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Device Name: use with the Family of Soprano XL Multi-Application Platforms

Indications for Use:

The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use in dermatologic and general surgical procedures.

The Alma Lasers Modified Diode Laser Module (used with the Alma Lasers Family of Soprano XL Multi-Application Platforms):

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

The Alma Lasers Family of Soprano XL Multi-Application Platforms 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 o

ice of Device Evaluation (ODE)
Nailer Odom for mxen

orative Devices

510(k) Number K112031

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