Harmony XL Multi-Application Platform

K181298 · Alma Lasers, Inc. · ONF · Jun 13, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K181298
• Device Name: Harmony XL Multi-Application Platform
• Applicant: Alma Lasers, Inc.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Jun 13, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dye VL Handpiece (500-600 nm) is indicated for: - The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker's Nevi. - The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. - The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. - Use on skin types (Fitzpatrick I-V).

Device Story

Harmony XL Multi-Application Platform is a console-based laser/light system for dermatological procedures. The Dye VL handpiece delivers intense pulsed light (500-600 nm) to target pigmented and vascular cutaneous lesions. The system comprises a console, footswitch, and interchangeable handpieces; it utilizes a system controller, power supply, and cooling system. Operated by clinicians in a clinical setting, the device emits light energy absorbed by chromophores in the skin to treat lesions. The output is controlled via the console interface. Benefits include non-invasive treatment of various skin conditions. The device is a modification of existing cleared platforms, maintaining identical principles of operation.

Clinical Evidence

Bench testing only. Evidence includes software verification and validation, electrical safety testing per IEC 60601-1, electromagnetic compatibility testing per IEC 60601-1-2, and biocompatibility testing of patient-contacting components per ISO 10993.

Technological Characteristics

Intense Pulsed Light (IPL) instrument. Wavelength: 500-600 nm. Console-based system with system controller, power supply, cooling system, and footswitch. Patient-contacting components tested for biocompatibility per ISO 10993. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Fitzpatrick skin types I-V.

Indications for Use

Indicated for treatment of benign pigmented lesions (e.g., café-au-lait, lentigines, freckles, chloasma, nevi), other pigmented cutaneous lesions (verrucae, skin tags, keratosis, plaques), and benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, poikiloderma, leg veins) in patients with Fitzpatrick skin types I-V.

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

• Harmony XL™ Multi-Application Platform and Thermoelectric Cooler (K072564)
• Alma Harmony Lite (K141237)

Submission Summary (Full Text)

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June 13, 2018

Alma Lasers Inc. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103

Re: K181298

Trade/Device Name: Harmony 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: ONF Dated: May 16, 2018 Received: May 16, 2018

Dear Janice Hogan:

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 of medical device-related adverse events) (21 CFR 803); good

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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.

Also, please note the regulation entiled, "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 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.

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

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

#### K181298

Device Name

### Harmony XLTM Multi-Application Platform (with the Dye VL Handpiece)

Indications for Use (Describe)

The Dye VL Handpiece (500-600 nm) is indicated for:

- The treatment of benign pigmented lesions including café -au-lait (macules), lentigines ● (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker's Nevi.
- The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, ● and plaques.
- . The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
- Use on skin types (Fitzpatrick I-V). ●

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FORM FDA 3881 (1/14)

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# 510(k) SUMMARY - K181298

# Alma Lasers, Inc.'s Harmony XL™ Multi-Application Platform

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

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

Phone: [phone] (Ext 2019) Email: [e-mail]

Date Prepared: June 6, 2018

## Name of Device

Harmony XL™ Multi-Application Platform

# Common or Usual Name

Intense Pulsed Light Instrument

### Classification

21 CFR 878.4810, Class II, product code ONF

### Predicate Devices

- Harmony XL™ Multi-Application Platform and Thermoelectric Cooler (K072564) ● (Primary Predicate)
- . Alma Harmony Lite (K141237) (Predicate)

### Intended Use / Indications for Use

The Dye VL Handpiece (500-600 nm) is indicated for:

- O The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma. nevi, nevus spillus, nevus of Ota, and Becker's Nevi.
- The treatment of other pigmented cutaneous lesions including verrucae, skin tags, o keratosis, and plaques.
- The treatment of benign cutaneous vascular lesions including port wine stains, o hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

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- o Use on skin types (Fitzpatrick I-V).
# Device Description

The Harmony XL™ continues to be comprised of the identical console unit, footswitch, and a variety of handpieces. The main console of the Harmony XL™ continues to consist of the same control panel, system controller, power supply modules, cooling system, switching module, and isolation transformer.

## Comparison of Technological Characteristics

The subject change is to add a version of the 515-950 nm SVL515 Module AFT handpiece ("SVL515") provided in the company's cleared Harmony XL™ (K072564) to the Harmony XL™ system. The modified handpiece has a narrowed wavelength range of 500-600 nm as compared to the SVL515 handpiece that has a wavelength of 515-950 nm. In addition, the modified handpiece is named the "Dye VL handpiece." Further, the identification color of the distal end of the handpiece is being changed from turquoise to light green.

With regard to indications for use, the intended use/indications for use of the Dye VL handpiece are the same as the primary and secondary predicate devices. Specifically, the Dye VL handpiece consists of a subset of the indications for use of the 532 nm Long Pulsed and Q-Switched FD Nd: YAG Laser Module Handpiece ("532 nm handpiece") included in the primary predicate. Both the subject handpiece and the 532 nm handpiece are indicated for the treatment of benign pigmented lesions including café-au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, Becker's Nevi and other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. Further, the indications for use of both the subject Dye VL handpiece and the SVL515 included in both the primary and secondary predicate device are indicated for the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations and are indicated to be used on skin types Fitzpatrick I-V. Therefore, the indications for use of the subject device are the same as its predicates.

### Performance Data

- . Software verification and validation was performed, and demonstrates that the software performs as intended.
- . Electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) was established.
- Biocompatibility of patient-contacting components was established per ISO 10993. .

In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate devices.

### Substantial Equivalence

The Harmony XLT™ has the same intended use/indications for use, as well as very similar

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technological characteristics, and identical principles of operation as its predicate devices. The minor technological differences between the subject and predicate devices do not raise new questions of safety or effectiveness.

# Conclusion

The minor technological differences between the subject and predicate devices do not raise new or different questions of safety or effectiveness. Design verification activities demonstrated that the device performs as intended and thus is substantially equivalent.