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 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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Alma Lasers Harmony XL™ Multi-Application Platform with the Dye VL Handpiece. This document is a regulatory submission to the FDA for demonstrating substantial equivalence to a predicate device, not a detailed scientific study on device performance against specific acceptance criteria. Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets them is limited and largely not present in the provided text.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific acceptance criteria (e.g., in terms of clinical efficacy metrics like lesion reduction percentage, or safety metrics like adverse event rates) and reported device performance against those criteria.

The "Performance Data" section states:

"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."

This indicates that the acceptance criteria are based on fulfilling engineering and safety standards, and that device functions as intended. However, the specific quantitative or qualitative criteria are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not mention any clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). The performance data cited refers to engineering verifications and validations (software, electrical safety, EMC, biocompatibility), which typically do not involve human subjects or clinical data in the same way as a clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not available in the document, as no clinical test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not available, as no clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in the device. The device is a laser/light platform, not an imaging analysis or diagnostic AI device. Therefore, this question is not applicable to the provided document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical laser/light therapy platform, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the engineering performance data mentioned, the "ground truth" would be established by the relevant engineering standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and the functional specifications of the device. There is no mention of clinical ground truth (like pathology or outcomes data) because the document focuses on demonstrating substantial equivalence based on technological characteristics and safety, rather than presenting new clinical efficacy data.

8. The sample size for the training set

The document does not mention any training set. This device is not described as an AI/ML device that would require a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable, as no training set for an AI/ML component is mentioned.

Summary of what is present:

The document is a 510(k) summary for a medical device (Harmony XL™ Multi-Application Platform with Dye VL Handpiece). It aims to demonstrate substantial equivalence to existing predicate devices, not necessarily to prove new clinical efficacy.

Acceptance Criteria (Implied): The device is stated to meet the "same acceptance criteria as the predicate devices" for software, electrical safety, electromagnetic compatibility, and biocompatibility. These criteria are based on established engineering and safety standards (IEC 60601-1, ISO 10993) and the device's functional specifications. Specific quantitative or qualitative performance targets are not listed.
Study: The "studies" conducted are non-clinical:
- Software verification and validation.
- Electrical safety testing (IEC 60601-1).
- Electromagnetic compatibility testing (IEC 60601-1-2).
- Biocompatibility testing (ISO 10993).
Sample Size/Data Provenance/Experts/Adjudication/MRMC/Standalone Performance/Ground Truth (for clinical data or AI): These details are not provided because the 510(k) submission primarily relies on demonstrating that the modified device's technological characteristics and intended use are substantially equivalent to a cleared predicate, and that it conforms to relevant engineering and safety standards. It does not describe a clinical performance study using patient data and expert review.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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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: 224-377-2000 (Ext 2019) Email: Rekha.Anand@almalasers.com

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

Comparison of Technological Characteristics

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.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.