The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include:

The Super Hair Removal (SHR) Mode is intended for temporary hair reduction.

The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for the Soprano Trio diode laser HR module include: Benign vascular and vascular dependent lesions.

810nm Applicator

Soprano Titanium 810 nm applicator intended use and indications for use:

The indications for use for the 810nm Modified Diode Laser Module 2 cm2 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)

755nm applicator

Soprano Titanium 755 nm applicator intended use and indications for use:

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.

· Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)

NIR Applicator

NIR Applicator intended use and indications for use

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 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.

Device Description

The Alma Lasers Soprano Titanium Laser System consists of:

System console (contains the laser diodes, the system software, power supply and various other electronic and mechanical parts)
Operator control panel with touch screen technology (GUI)
810 nm applicator ●
755 nm applicator
Small NIR applicator
Trio 4 cm2 applicator ●
Trio 2 cm2applicator .

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, asserting the Alma Soprano Titanium device's substantial equivalence to a predicate device (K222064). This means that the device is deemed to be as safe and effective as a previously cleared device. Therefore, a separate study to prove the device meets acceptance criteria is not explicitly provided in this document, as the substantial equivalence framework relies on comparison to an already approved device.

However, based on the provided text, we can infer some information about performance testing and clinical data:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in a table format for the newly submitted device. Instead, it refers to performance testing against established safety and essential performance standards for medical electrical equipment and laser products. The implicit "performance" is that the device conforms to these standards.

Acceptance Criteria (Inferred from regulatory standards)	Reported Device Performance (Inferred from submission)
Compliance with general requirements for safety and essential performance (e.g., ANSI/AAMA ES 60601-1)	Tested and found compliant.
Compliance with particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment (e.g., IEC 60601-2-22)	Tested and found compliant.
Compliance with safety of laser products - equipment classification and requirements (e.g., IEC 60825-1)	Tested and found compliant.
Compliance with particular requirements for basic safety and essential performance of non-laser light source equipment (e.g., IEC 60601-2-57)	Tested and found compliant.
Software verification and validation (e.g., IEC 62304)	Performed and found compliant.
Biocompatibility conformance to FDA standards	Established and found compliant.
Fluence remains the same for the new Trio 2 cm2 handpiece as the cleared Trio 4 cm2 handpiece.	Confirmed.
New Smart Clinic software functions as a Medical Device Data System (MDDS) within FDA guidance.	Confirmed.

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 states, "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission." This indicates that there was no new clinical test set for this specific 510(k) submission. The device's safety and effectiveness are established through its substantial equivalence to the predicate device K222064.

Therefore, questions regarding sample size, data provenance (country of origin, retrospective/prospective), number of experts, and adjudication methods for a test set are not applicable to this submission, as no new clinical test data was generated.

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):

Not applicable, as no new clinical studies were conducted for this submission.

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

Not applicable, as no new clinical studies were conducted for this submission.

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:

Not applicable. The Smart Clinic software is classified as an MDDS (Medical Device Data System), which is focused on data management and display, not AI-assisted diagnosis or interpretation requiring MRMC studies.

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

Not applicable. The document focuses on hardware (laser modules, applicators) and an MDDS software component. There is no mention of a standalone algorithm for diagnostic or interpretative purposes.

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

Not applicable to this 510(k) submission directly, as it relies on substantial equivalence. The "ground truth" for the predicate device (K222064) would have been established through its own clearances and supporting data, which is not detailed here. For the current submission, the "ground truth" is that the device conforms to the relevant performance standards mentioned in Section VII and maintains similar technical characteristics to the predicate.

8. The sample size for the training set:

Not applicable, as no new clinical studies involving training sets for algorithms are mentioned or deemed necessary for this submission. The Smart Clinic software is an MDDS and does not appear to involve a learning algorithm requiring a training set in the context of this document.

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

Not applicable, as no new clinical studies involving training sets for algorithms are mentioned or deemed necessary for this submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 22, 2023

Alma Lasers Inc. % Kathy Maynor Regulatory Consultant Kathy Maynor consulting 26 Rebecca Ct Homosassa, Florida 34446

Re: K230371

Trade/Device Name: The Alma Soprano Titanium 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, OUG Dated: February 10, 2023 Received: February 13, 2023

Dear Kathy Maynor:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jianting Wang -S

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230371

Device Name Soprano Titanium

Indications for Use (Describe)

The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include:

The Super Hair Removal (SHR) Mode is intended for temporary hair reduction.

The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode include: Benign vascular and vascular dependent lesions.

810nm Applicator

Soprano Titanium 810 nm applicator intended use and indications for use:

The indications for use for the 810nm Modified Diode Laser Module 2 cm2 include:

Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)

755nm applicator

Soprano Titanium 755 nm applicator intended use and indications for use:

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.

· Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)

NIR Applicator

NIR Applicator intended use and indications for use

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 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.

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)

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Section 8 510(k) Summary

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 100Buffalo Grove, IL 60089
Contact Person	Kathy MaynorRegulatory ConsultantEmail : regulatory@almalasers.comPhone: 224-377-2019 or 2150Facsimile: 646-805-1305
Summary Preparation Date	February 10, 2023

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

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

Trade or Proprietary Name	Soprano Titanium
Common Device Name(s) andRegulatory Class	ProductCode(s)	Classification Panel	Regulation
Powered Laser SurgicalInstrument Class II	GEX	General & PlasticSurgery Panel, 79(SU)	§ 21 CFR 878.4810
Lamp, Infrared TherapeuticHeating Class II	ILY	General & PlasticSurgery Panel 79	§ 21 CFR 890.550
Medical Device Data System	OUG	General HospitalPanel 80	§ 21 CFR 880.6310

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

Type	510(k) #	Trade Name	Product Code
Primary	K222064	Alma Lasers Soprano Titanium	GEX, ILY

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

The Alma Lasers Soprano Titanium Laser System consists of:

System console (contains the laser diodes, the system software, power supply and various other electronic and mechanical parts)
Operator control panel with touch screen technology (GUI)
810 nm applicator ●
755 nm applicator
Small NIR applicator
Trio 4 cm2 applicator ●
Trio 2 cm2applicator .

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

The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include:

The Super Hair Removal (SHR) Mode is intended for temporary hair reduction.

810nm Applicator

Soprano Titanium 810 nm applicator intended use and indications for use:

The indications for use for the 810nm Modified Diode Laser Module 2 cm2 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)

755nm applicator

Soprano Titanium 755 nm applicator intended use and indications for use:

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.

· Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)

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NIR Applicator

NIR Applicator intended use and indications for use

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 strains, and minor muscular back pain.

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

This submission introduced two product changes - the addition of a Trio 2 cm2 handpiece (with optional tapered light guide) and the incorporation of software module Smart Clinic, an MDDS software system.

The Trio 4 cm2 handpiece was cleared in K222064. The addition of a Trio 2 cm2 handpiece (with optional tapered light guide) does not raise any new questions on safety or efficacy because the fluence remains the same, and it is the fluence that determines the therapeutic effect on the skin. The indications for use for the new Trio 2 cm2 handpiece is exactly the same as the currently cleared Trio 4 cm2 handpiece.

The new Smart Clinic software is classified as MDDS (medical device data system) software by FDA guidance document Medical Device Data Systems, Medical Image Storage Devices and Medical Image Communications Devices dated September 2022. MDDS software does not require a submission, but since it is part of the system software, it was included in the software verification and validation activities.

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

ANSI/AAMA ES 60601-1 Medical Electrical Equipment - Part 1: General Requirements for safety and essential performance

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 60825-1, Safety of laser products - Part 1: Equipment classification, and requirements

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IEC 60601-2-57 - Medical Electrical Equipment - Part 2-57: Particular Requirements for the Basic Safety and Essential Performance of Non-Laser Light Source Equipment Intended for Therapeutic, Diagnostic, Monitoring and Cosmetic/Aesthetic Use

In addition, software verification and validation testing was performed to the requirements of IEC 62304 and biocompatibility conformance to FDA standards was established.

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

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

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

The Alma Lasers Soprano Titanium laser system is as safe and effective as the predicate K222064. The proposed Alma Lasers Soprano Titanium laser system has the same intended use and indications, similar technological characteristics, and same principle of operation as its predicate device. Thus, the Alma Lasers Soprano Titanium laser system is substantially equivalent to its predicate.

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.