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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for K112031:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K112031 510(k) Summary) does not explicitly list "acceptance criteria" in a quantitative, measurable format for this device submission. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly defined by the safety and effectiveness demonstrated in peer-reviewed literature for similar technology.

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance (from literature)
Safe for dermatologic and general surgical procedures	Demonstrated safety and effectiveness in 2,879 patients.
Effective for hair removal	Demonstrated safety and effectiveness for hair removal.
Effective for permanent hair reduction	Demonstrated safety and effectiveness for permanent hair reduction.
Effective for treatment of benign vascular lesions	Demonstrated safety and effectiveness for treatment of benign vascular lesions (implied by predicate, not explicitly re-stated with data for this device).
Effective for treatment of pigmented lesions	Demonstrated safety and effectiveness for treatment of pigmented lesions (implied by predicate, not explicitly re-stated with data for this device).
Usable on all skin types (Fitzpatrick I-VI), including tanned skin	Demonstrated safety and effectiveness on Fitzpatrick skin types I-VI, including tanned skin.
Performance immediately following treatment	Studies reported safety and effectiveness immediately following treatment.
Long-term performance (1, 6, and 18 months post-treatment)	Studies reported safety and effectiveness at 1, 6, and 18 months following treatment.
Low fluence, high repetition rate, multiple-pass treatment regimen	Demonstrated safety and effectiveness using these parameters.

Note: The FDA's substantial equivalence determination for this 510(k) means they found the device as safe and effective as legally marketed predicate devices. The acceptance criteria are therefore aligned with the demonstrated performance of those predicate devices and the clinical literature supporting the technology.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for the Test Set: 2,879 patients
Data Provenance: The document states "published peer-reviewed medical literature provided device validation information." This indicates the data is retrospective, drawn from previously conducted clinical studies. The country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not provided or required for 510(k) submissions, especially when relying on published literature for substantial equivalence for a physical device like a laser. The evaluation of "ground truth" (e.g., successful hair removal, lesion treatment) would have been performed by the clinicians conducting the studies, but their specific number or qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Given that the submission relies on existing published literature for device validation (rather than new clinical trials), there's no mention of a specific adjudication method for the "test set" in this context. The peer-review process of the scientific literature would have served as the form of validation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Information

MRMC Study Done? No. This type of study (comparing human readers with and without AI assistance on multiple cases) is typically associated with AI/CAD image analysis devices. This submission is for a physical laser device, not an AI diagnostic tool.
Effect Size of Human Readers with vs. Without AI Assistance: Not applicable.

6. Standalone Performance (Algorithm Only) Study Information

Standalone Performance Study Done? No. This concept is relevant for AI algorithms. This submission is for a physical laser device.

7. Type of Ground Truth Used

The ground truth was established by clinical outcomes observed and reported in the published peer-reviewed medical literature. This would include direct clinical assessment of:

Hair removal status
Degree of permanent hair reduction
Effectiveness of treatment for benign vascular lesions (implied by predicate and technology type)
Effectiveness of treatment for pigmented lesions (implied by predicate and technology type)
Safety outcomes (adverse events, skin reactions, etc.)

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "training" for the device's development would be through engineering and testing, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of machine learning for this physical device.

Summary

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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/510(k) Owner	Sponsor
Address andEstablishmentRegistration #	Alma Lasers, Inc.485 Half Day Rd. Suite No. 100Buffalo Grove, IL 60089, USAFDA Registration #: 3004167969
ContactPerson:	Tatiana EpsteinVP QA&RAAlma Lasers, Inc.	Telephone: (224) 377-2011Facsimile: (224) 377-2050Email: Tatiana.epstein@almalasers.com

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 plasticsurgery 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

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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K112031 Pg 2 of 3

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	K11Alma Lasers Modified Diode Laser Modulewith SHR Treatment Mode used with theSoprano XL Multi-Application Platforms			K102716Modified Alma Lasers Family ofSoprano Multi-ApplicationPlatforms [Soprano XLTM,Soprano XLiTM]		K083848Alma LasersSoprano XL Multi-ApplicationPlatform
DiodeModuleMode	SHR Mode	HR Mode	LB Mode	HR Mode	LB Mode	HR Mode
LaserWavelength	810 nm (nominal)			810 nm (nominal)		810 nm (nominal)
Indicationsfor Use	Intended for hair removal,permanent hair reduction		Intended fortreatment ofbenign vascularand pigmentedlesions	Intended for hairremoval,permanent hairreduction	Intended fortreatment ofbenign vascularand pigmentedlesions	Intended for hairremoval, permanenthair reduction
SopranoSystemIndicationsfor Use	• Intended for use in dermatologic and general surgical procedures• 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(EnergyDensity)	≤ 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
PulseDuration	≤ 20 ms	5-200 ms		5-200 ms		5-200 ms
CompatibleLaser Syst.	Used with Family of Soprano XL Multi-Application Platforms			Family of Soprano XL Multi-Application Platforms		Soprano XL System

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K112031 Pg 3 of 3

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 (800) 638-2041 or (301) 796-7100 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

Page 1 of l

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.