The SOPRANO™ Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The SOPRANO™ System is indicated for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Device Description

The modified MSq SOPRANO™ Hair Removal Diode Laser System is comprised of the following components:

Console Unit that includes the main CPU Board, Power Supply Units, . Control Panel, Service Panel, Cooling System, Keyswitch, Emergency Stop, and Isolating Transformer;
Handpiece (with Connector) that includes Optical Head, Tissue Cooling . system (the cold plate) and Handpiece Trigger;
Footswitch. .

AI/ML Overview

The provided document is a 510(k) summary for the MSq SOPRANO™ Hair Removal Diode Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria in the manner typically seen for novel medical diagnostics or AI software.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and the specifics of a study proving the device meets those criteria, such as sample sizes, expert qualifications, adjudication methods, or MRMC studies.

Instead of specific acceptance criteria met by the device itself, the document focuses on demonstrating substantial equivalence to a predicate device.

Here's what can be extracted based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document does not describe specific performance metrics or acceptance criteria for the SOPRANO™ system in terms of clinical outcomes (e.g., success rates, hair reduction percentages) and how they were met by a study.
The "acceptance criteria" in this context is "substantial equivalence" to the predicate device, MSq MYTHOS™ Hair Removal Diode Laser System (K030805), based on shared indications for use, device operation, and overall technical and functional capabilities. The document asserts that the SOPRANO™ system meets this criterion.

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

Not provided. The document does not describe a clinical "test set" with a specific sample size. The substantial equivalence argument relies on comparing technical specifications and overall capabilities to the predicate.

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

Not provided. This type of information is not relevant to a substantial equivalence argument for a laser hair removal system based on technical modifications.

4. Adjudication Method:

Not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is not mentioned or implied, as the device is not an AI diagnostic software requiring human reader evaluation.

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

Not applicable. The SOPRANO™ device is a laser system, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable. This concept does not apply to the 510(k) summary for this device. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

In summary: The provided 510(k) summary for the SOPRANO™ Hair Removal Diode Laser System demonstrates substantial equivalence to a predicate device by asserting shared indications for use, device operation, and technical/functional capabilities. It does not contain the detailed clinical study information (acceptance criteria, sample sizes, expert involvement, "ground truth" establishment, etc.) that would be expected for a novel device or AI-based diagnostic tool.

Summary

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ATTACHMENT 8 - 510(K) SUMMARY I.

K052874

Confidential

1. General Information
  Submitter:

Contact Person:

MSq. (M2) Ltd. 7 Haeshel Street (P.O.Box 3021) Caesarea Industrial Park Caesarea 38900. Israel Tatiana Epstein Regulatory Affairs Manager

Summary Preparation Date:

Names

Device Names:

SOPRANO™ Hair Removal Diode Laser System

Primary Classification Name:

Surgical Powered Laser Instrument

3. Predicate Device

MSq MYTHOSTM Hair Removal Diode Laser System (K030805) .
October 23, 2005

4. Product Description

The modified MSq SOPRANO™ Hair Removal Diode Laser System is comprised of the following components:

Console Unit that includes the main CPU Board, Power Supply Units, . Control Panel, Service Panel, Cooling System, Keyswitch, Emergency Stop, and Isolating Transformer;
Handpiece (with Connector) that includes Optical Head, Tissue Cooling . system (the cold plate) and Handpiece Trigger;
Footswitch. .

5. Indications for Use

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6. Rationale for Substantial Equivalence

The modified MSq SOPRANO™ Hair Removal Diode Laser System shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate MSq MYTHOS™ Hair Removal Diode Laser System (K030805).

7. Safety and Effectiveness Information

The review of the indications for use, technical characteristics, risk analyses, and verification and validation information provided demonstrate that the modified MSq SOPRANO™ Hair Removal Diode Laser System is substantially equivalent to the predicate device.

8. Conclusion

The modified MSq SOPRANO™ Hair Removal Diode Laser System was found to be substantially equivalent to the predicate MSq MYTHOS™ Hair Removal Diode Laser System (K030805).

The modified MSq SOPRANO™ Hair Removal Diode Laser System shares identical indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Public Health Service

NOV 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tatiana Epstein Regulatory Affairs Manager MSq. (M2) Ltd. 7 Haeshel Street (P.O. Box 3021) Caesarea Industrial Park Caesarea 38900, Israel

Re: K052874

Trade/Device Name: SOPRANO™ Hair Removal Diode Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 26, 2005

Received: October 28, 2005

Dear Ms. Epstein:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2-Tatiana Epstein

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buckland

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 2 - INDICATIONS FOR USE STATEMENT AS C. REQUESTED BY FDA

510(k) Number (if known)

K 052874

Device Name SOPRANO™ Hair Removal Diode Laser System

The SOPRANO™ Hair Removal Diode Laser is intended for hair Indications for Use removal and permanent hair reduction. The SOPRANO™ System is indicated for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801. 109)

OR Over-The-Counter Use
Carlaue Buchem

Sign-Off Division of General, Restorative, and Neurological Devices

Special 510 (k) Submission for SOPRANO™

Attachment 2 - Page C-1

510(k) Number K052874

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.