Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules

K172193 · Alma Lasers, Inc. · GEX · Jan 9, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K172193
• Device Name: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
• Applicant: Alma Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The device is intended for use in dermatologic and general surgical procedures. The Soprano trio Diode Laser Module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio Diode Laser Module include: - Benign vascular and vascular dependent lesions removal. The indications for use for the Soprano1064nm Diode Laser Module include: - The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. - Treatment of Pseudo folliculitis Barbae (PFB) - Use on all skin types (Fitzpatrick I-VI), including tanned skin. The indications for use for the 810nm Modified Diode Laser Module 1.2 cm' include: - The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. - The treatment of benign vascular and pigmented lesions.(The Laser Blanch (LB) Mode) - Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and LB Modes) The indications for use for the 810nm Modified Diode Laser Module 2 cm include: - The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. - Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes) The indications for use for the 755nm Diode Laser Module include: - The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. - The treatment of benign vascular and pigmented lesions.(The Laser Blanch Mode) - Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and Laser Blanch Modes) The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating. The indications for use for NIR Modules are: - 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 minor muscular back pain.

Device Story

Multi-application laser platform (Soprano XL family) utilizes diode laser modules to deliver energy to skin; Trio module combines 755nm, 810nm, and 1064nm wavelengths for simultaneous emission. System includes main console, footswitch, and interchangeable handpieces. Used in hospitals, clinics, and medical spas by trained professionals. Operator activates via footswitch; laser energy targets hair follicles or vascular/pigmented lesions via thermal coagulation. NIR modules provide topical heating for pain relief. Output allows clinicians to perform dermatologic/surgical procedures. Benefits include permanent hair reduction and relief of musculoskeletal pain.

Clinical Evidence

No clinical studies performed. Evidence based on bench testing (IEC 60601-1, 60601-1-2, 60601-2-22, IEC 60825-1), software verification/validation, biocompatibility, and animal histology. Animal study compared tissue effects of individual wavelengths vs. combined Trio module across energy ranges, showing no significant differences in safety or effectiveness.

Technological Characteristics

Diode laser platform; Trio module combines 755nm, 810nm, 1064nm wavelengths. Energy delivered via handpiece tips. NIR modules emit near-infrared pulsed light. Complies with IEC 60601-1, 60601-1-2, 60601-2-22, and IEC 60825-1. Reusable, non-sterile components. Software-controlled console.

Indications for Use

Indicated for permanent hair reduction (all skin types I-VI, including tanned), treatment of Pseudo folliculitis Barbae, and removal of benign vascular/pigmented lesions. NIR modules indicated for temporary relief of minor muscle/joint pain, stiffness, arthritis pain, muscle spasms, sprains, and increased local circulation.

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 Soprano XL Family of Multi-Application and Multi-Technology Platforms (K140009, K170626)

Reference Devices

• Cynosure Cynergy Multiplex Laser (K050779)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

January 9, 2018

Alma Lasers Inc. c/o Rekha Anand Senior Regulatory Affairs Associate 485 Half Day Road Suite # 100 Buffalo Grove, Illinois 60089

Re: K172193

Trade/Device Name: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules 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, ILY Dated: December 12, 2017 Received: December 13, 2017

Dear Rekha Anand:

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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known) K 172193

### Device Name

# Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms (SopranoXL, SopranoXLi, Soprano 105 and Soprano 100 Platinum] with Trio Diode Laser Module

### Indications for Use (Describe)

### Intended Use

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

### Indications for Use

The Soprano trio Diode Laser Module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio Diode Laser Module include:

- Benign vascular and vascular dependent lesions removal. ●
The indications for use for the Soprano1064nm Diode Laser Module include:

- · The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- · Treatment of Pseudo folliculitis Barbae (PFB)
- · Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The indications for use for the 810nm Modified Diode Laser Module 1.2 cm' include:

- . The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- The treatment of benign vascular and pigmented lesions.(The Laser Blanch (LB) Mode)
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and LB Modes)

Optional Tapered Light Guide: It is intended for the same use as the device.

The indications for use for the 810nm Modified Diode Laser Module 2 cm include:

- The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair ● regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes) ●

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

The indications for use for the 755nm Diode Laser Module include:

- The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair ● regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- The treatment of benign vascular and pigmented lesions.(The Laser Blanch Mode)
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and Laser Blanch Modes) ●

# NIR Modules

The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating.

The indications for use for NIR Modules are:

- 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 minor muscular 0 back pain.

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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services [phone] EF

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

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

| Owner Name | Alma Lasers Inc. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 485 Half Day Rd. Suite 100<br>Buffalo Grove, IL 60089 |
| Contact Person | Rekha Anand<br>Senior Regulatory Affairs Associate<br>Email : [e-mail]<br>Phone: [phone] or 2150<br>Facsimile: 646-805-1305 |
| Summary Preparation Date | Dec 12, 2017 |

#### I. Submitter Information [21 CFR 807.92(a) (1)]

#### II. Name of device [21 CFR 807.92 (a) (2)]

| Trade or Proprietary Name | Modified Alma Lasers Soprano XL™ Family of Multi-<br>Application and Multi-Technology Platforms<br>[SopranoXL, SopranoXLi, SopranoICE and Soprano ICE<br>Platinum] with Trio Module | | | |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------|--|
| Common Device Name(s) and<br>Regulatory Class | Product<br>Code(s) | Classification Panel | Regulation | |
| Laser Powered Surgical<br>Instruments (& Accessories)<br>Class II | GEX | General & Plastic<br>Surgery Panel, 79 (SU) | § 878.4810, Laser surgical<br>instrument for use in general and<br>plastic surgery and dermatology | |
| Surgical Powered Lasers and Delivery Devices/Hand piece<br>Accessories | | | | |
| Lamp, Infrared, Therapeutic<br>Heating<br>Class II | ILY | General & Plastic<br>Surgery Panel, 79 (SU) | § 890.5500-Lamp, Infrared,<br>Therapeutic Heating | |
| | Lamp, Infrared | | | |

#### III. Predicate Devices [21 CFR 807.92(a) (3)]

| Type | 510(k) # | Trade Name |
|-----------|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary | K140009,<br>K170626 | Modified Alma Lasers Soprano XLTM Family of<br>Multi-Application and Multi-Technology<br>Platforms [SopranoXL, SopranoXLi, and Soprano<br>ICE] |
| Reference | K050779 | Cynosure Cynergy Multiplex Laser |

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

#### IV. Device Description [21 CFR 807.92(a) (4)]

The subject device, Alma Lasers Soprano Trio Diode Laser Module is an additional hand piece intended to be used with previously cleared Soprano platforms. Consistent with the previous clearance the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are still the main console unit, foot switch, and individual modules. No change has been made to the main console unit except for incorporation of the software needed to run the new module and adding a new device name (Soprano 100 Platinum) to the Soprano family name for marketing purposes. The footswitch and pre-existing modules are also unmodified from those cleared in K140009 and K170626.

The module's operation involves emission of laser (diode) energy through the hand piece to the patient's skin. The materials that could contact the patient during device use are as cleared in the predicate. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.

#### V. Intended use of device and Indications for Use [21 CFR 807.92(a) (5)]

# Intended Use

The Soprano Trio module is intended for use in dermatology procedures requiring coagulation.

# Indications for Use

The indications for use for the Soprano Trio Diode Laser Module include:

- · Benign vascular lesions and vascular dependent lesions removal
There is no change in intended use and indications for use for the existing Diode 810nm, 755nm, 1064nm and NIR hand pieces.

#### VI. Summary of technological characteristics of the device compared to the predicate[21 CFR 807.92(a)(6)]

There is no change in intended use or indications for use for the existing 755nm, 810mm and 1064nm diode laser hand pieces or the near-infrared light (NIR) hand pieces of the cleared Sopranotes platform. Thus, there is only an addition of one new diode module, the Trio Module, composed of 755nm, 810m, and 1064nm wavelengths with similar intended and indications for use.

The technological principles underlying the subject device and its prior legally marketed iteration (the Soprano CE platform cleared in K140009, K170626) are the same. Operation of the new diode laser module involves activation of foot switch and delivery of diode

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

laser energy through the tip built into the corresponding handpiece, just as use of the device with the previously cleared laser modules involves delivery of laser energy through the different-sized tips of the selected handpiece, or through the tapered light guide tip for treating smaller areas. The NIR modules have not been modified since their clearance in K140009; they emit pulsed-light energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, temporary increase in local circulation, and muscle relaxation.

Energy source type and parameters are the same as in prior iteration of the device. The only technological difference in the subject device as compared to the prior iteration of the Soprano platform (K140009, K170626) is combining three (Trio Module) wavelengths into a single hand piece being simultaneously fired.

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

#### VII. Performance Testing [21 CFR 807.92(b)(1)]

IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for safety IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance

IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60825-1Safety of laser products-Part 1: Equipment Classification, requirements and user's guide

In addition software verification and validation testing was performed and biocompatibility was established.

In addition animal histology testing was performed to ascertain that there were no new safety or effectiveness issues raised by this modification. The animal histology compared the histology of the individual wavelengths compared to the histology of the combined wavelengths over a range of energies from lowest to highest. Testing showed no significant differences between the individual tissue effects and the combined wavelength tissue effects.

In all instances, the Soprano Trio Diode Laser Module functioned as intended and the results observed were as expected.

#### VIII. Clinical Data [21 CFR 807.92(b) (2)]

Based on the similarities in the safety and effectiveness profiles of the subject, primary predicate and reference devices, no clinical studies were deemed needed to support this submission.

#### IX. Conclusions Safety and Effectiveness SE [21 CFR 807.92(b) (3)]

The Soprano Trio Diode Laser Module is as safe and effective as the primary predicate Alma Lasers Soprano XL TM Family of Multi-Application Platforms [Sopranox], SopranoxHi, and Soprano CE] (K140009, K170626) and reference predicate Cynosure Cynergy Multiplex laser (K050779) The proposed Trio diode laser module has similar intended use and indications, similar technological characteristics, and same principle of operation as its predicate device. Combining different wavelengths in one module does not alter the intended use of the device and does not affect its safety and effectiveness when used as labeled. Thus, the Soprano Trio Diode Laser Module is substantially equivalent.