Magma Spark device has connection capability with the follo\ving available treatment hand-pieces (applicators), for multiapplication treatment options. All hand-pieces are designed for aesthetic demlatologic procedure applications. Magma Spark device \vith ALD or LLD diode laser applicators is indicated for hair removal, pennanent hair reduction* in skin types I-VI and for the treatment of pseudofolliculitis barbae (PFB).

(*Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after completion of treatment regime)

Device Description

The Magma Spark device is a computerized multi-application platform intended for non-invasive aesthetic applications utilizing laser optical power.

Magma Spark is a relatively small tabletop device that provided with melanin meter and two diode laser applicators (ALD and LLD) at nominal 808 nm wavelength. The system platform includes AC/DC power supply unit, water based cooling system, CPU main card and user interface including an LCD display and touch screen module. The operator of Magma Spark chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the device.

AI/ML Overview

This document is a 510(k) Summary for the Magma Spark device, a laser system for aesthetic applications in dermatology. It claims substantial equivalence to a predicate device, Magma. The document does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance data) that would typically be associated with a device proving it meets acceptance criteria, especially for a new or significantly modified device.

Instead, the document details a Special 510(k) Summary, which is used when a modification to a previously cleared device does not affect its safety and effectiveness. The core argument for substantial equivalence is that the Magma Spark device is essentially the same as its predicate device (Magma K153566), particularly for diode laser applications, and any changes are minor.

Therefore, many of the requested data points are explicitly stated as "Not Applicable" or are addressed by referring to the predicate device's prior clearance.

Here's a breakdown based on the provided text, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative "reported device performance" in the way one might expect for a de novo submission or a device with new clinical claims. Instead, the "performance" is implicitly deemed equivalent to the predicate device, especially regarding safety and efficacy for the specified indications.

The key "performance" claimed is the ability to perform the stated Indications for Use: hair removal, permanent hair reduction in skin types I-VI, and treatment of pseudofolliculitis barbae (PFB). The definition of permanent hair reduction is provided: "long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after completion of treatment regime." However, no new study data is provided in this document to demonstrate Magma Spark meets these criteria specifically. The implicit acceptance criterion is that its performance is equivalent to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance (Implied by SE claim)
Safety and Efficacy for hair removal, permanent hair reduction, and PFB in skin types I-VI, equivalent to predicate device (Magma K153566).	Magma Spark device is "substantially equivalent" to the predicate Magma device for the mentioned indication for use (hair removal, permanent hair reduction, PFB with diode laser applicators). The underlying technology and principle of operation are "essential the same." It has similar safety features and complies with the same relevant consensus standards as the predicate device.
Compliance with recognized consensus standards (for safety and electromagnetic compatibility).	Complies with:- AAMI/ANSI 60601-1 (2012)- IEC 60601-1-2 (Edition 3.0, 2007)- IEC 60825-1 (Edition 2.0, 2007)- IEC 60601-2-22 (Edition 3.0, 2007 & Edition 3.1 2012)
Software functionality, hardware interfaces, performance, load test, download procedure, integrity, recovery, and usability.	"Comprehensive software-system test plan and results report covers the full system test of the Magma Spark." (No detailed results provided in this summary).

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable. No new clinical or animal studies were conducted for this 510(k) submission to generate a "test set" in the traditional sense for evaluating new performance data. The submission relies on the substantial equivalence to the predicate device.
Data Provenance: Not applicable for new performance data. The device's substantial equivalence is based on its similarity to the predicate device, which would have undergone its own studies. The only new data mentioned relates to software testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new clinical studies are detailed in this document that would require experts to establish ground truth for a test set.

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

Not applicable. No new clinical studies are detailed in this document requiring an adjudication method.

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. This device is a laser system, not an AI or imaging diagnostic device that would typically involve human "readers" or MRMC studies.

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

Not applicable. This is a laser treatment device, not an algorithm, so "standalone" performance in this context is irrelevant. The device is intended for use by a human operator. The document does mention "Comprehensive software-system test plan and results report covers the full system test of the Magma Spark. It includes operation and user procedures, as well as programs. In addition to comprehensively testing firmware functionality, hardware interfaces, performance, load test, download procedure, integrity, recovery and usability." This describes internal software verification and validation, but not "standalone" clinical performance.

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

Not applicable for this submission. Any "ground truth" for the efficacy of hair removal or PFB treatment would typically come from clinical trials that measure hair count reduction or clinical improvement, but these were presumably done for the predicate device, not for this specific 510(k).

8. The sample size for the training set

Not applicable. The document discusses a physical medical device (laser system), not a machine learning algorithm that would have a "training set."

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

Not applicable. As above, this is not a machine learning algorithm.

Summary of Approach based on Document:

The acceptance criteria for the Magma Spark device in this 510(k) are primarily based on demonstrating substantial equivalence to a predicate device (Magma K153566). The "study" that proves the device meets (these implied) acceptance criteria is not a new clinical trial, but rather a comparative analysis of the Magma Spark to its predicate, highlighting:

Similar Technology and Principle of Operation: The underlying technology (diode laser at 808 nm) and mechanism of operation are "essential the same."
Equivalent Intended Use: The Magma Spark, with its diode laser applicators, has the same indications for use (hair removal, permanent hair reduction in skin types I-VI, and PFB) as the predicate's diode laser applications.
Compliance with Standards: Both devices comply with the same recognized consensus standards for safety and electromagnetic compatibility.
Software Verification and Validation: A comprehensive software system test was executed to ensure the functionality, performance, and safety of the Magma Spark's internal software. This is a bench test, not a clinical study.
No New Clinical or Animal Studies: The document explicitly states "Clinical Performance Data: Not Applicable" and "Pre-Clinical (Animal Study) Performance Data: Not Applicable."

In essence, the "proof" is that the device is not significantly different from an already cleared device, and thus its safety and effectiveness are presumed to be upheld.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 9, 2016

Formatk Systems Ltd. % Ahava Stein Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 IL

Re: K162781

Trade/Device Name: Magma Spark 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: September 29, 2016 Received: October 3, 2016

Dear Ahava Stein:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Jennifer R. Stevenson -A For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices

Center for Devices and Radiological Health

Office of Device Evaluation

Enclosure

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Indications for Use

510(k) Number (if known)

K162781 Device Name Magma Spark

Indications for Use (Describe)

Magma Spark device is indicated for use in aesthetic applications in dermatology.

(*Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after completion of treatment regime)

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

|ZJ Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 6: Special 510(k) Summary

510(K) SUMMARY

MAGMA SPARK DEVICE

510(k) Number K162781

Applicant Name:	Formatk Systems Ltd
Company Name:	Tavor Building, POB 533Yokneam Iillit 2069206 IsraelTel: +972-4-909-7440Fax: +972-4-909-7471E-mail: ahava@asteinrac.com
Contact Person:Official Correspondent:	Ahava Stein
Company Name:	A. Stein - Regulatory Affairs Consulting Ltd.
Address:	20 Hata'as Str., Suite 102Kfar Saba 4442520 IsraelTel: + 972-9-7670002Fax: +972-9-7668534E-mail: ahava@asteinrac.com
Date Prepared:	September 29, 2016
Trade Name:	Magma Spark
Classification Name:	CFR Classification section 878.4810 (Product code GEX)
Classification:	Class II Medical Device

Predicate Device:

Magma Spark device is substantially equivalent to the previously cleared, Magma device, also manufactured by Formatk Systems Ltd.

Device	Manufacturer	510(k) No.
Magma	Formatk Systems Ltd.	K153566

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Device Description:

The Magma Spark device is a computerized multi-application platform intended for non-invasive aesthetic applications utilizing laser optical power.

Main Line Frequency (nominal)	50 - 60 Hz
Input Voltage (nominal)	100 - 240 VAC
Input Current (A)	6.0 max
Platform dimensions (inch)	26.0"W x 21.7"D x 23.6"H
Platform weight (lb.)	50.7
ALD & LLD Diode laser wavelength (nm)	808
Maximal Fluence (J/cm2):
ALD	Up to 75
LLD	Up to 35

Device Specifications:

Intended Use/Indication for Use:

Magma Spark device is indicated for use in aesthetic and cosmetic applications in dermatology.

Magma Spark device has connection capability with the following available treatment hand-pieces (applicators), for multi-application treatment options. All handpieces are designed for aesthetic and cosmetic dermatologic procedure applications. Magma Spark device with ALD and LLD diode laser applicators iis indicated for hair removal, permanent hair reduction in skin types I-VI and for the treatment of pseudofolliculitis barbae (PFB).

Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after completions of treatment regime

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Section 6: Special 510(k) Summary

Performance Standards:

Magma Spark complies with the following recognized consensus standards:

. AAMI/ANSI 60601-1 (2012). Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod).
. IEC 60601-1-2 (Edition 3.0, 2007), Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
. IEC 60825-1 (Edition 2.0, 2007), Safety Of Laser Products - Part 1: Equipment Classification, And Requirements JIncluding: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)].
. IEC 60601-2-22 (Edition 3.0, 2007 & Edition 3.1 2012), Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment.

Non-Clinical (Bench) Performance Data:

The underlying technology and principle of operation of Magma Spark is essential the same as the predicate device. Therefore, results were gathered to support the safety of the modified device and thorough test of the software was executed. Comprehensive software-system test plan and results report covers the full system test of the Magma Spark. It includes operation and user procedures, as well as programs. In addition to comprehensively testing firmware functionality, hardware interfaces, performance, load test, download procedure, integrity, recovery and usability.

Pre-Clinical (Animal Study) Performance Data:

Not Applicable

Clinical Performance Data: Not Applicable

Substantial Equivalence:

The components of modified Magma Spark device, similarly to predicate Magma device, generate its mechanism of operation using the same underlying technology. Delivery of the laser energy through each specific applicator (either ALD or LLD) is monitored and controlled by the device's CPU. The user interface control panel

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provides the user with the optimal treatment settings taking into consideration the patient skin type and hair type (for hair removal treatments). Since Magma Spark device is limited to operate with diode laser applicators only, the intended use of Magma Spark device is same as predicate Magma device in relation to the diode laser-relevant applications only. Using both modified and cleared devices the device user can decide on the optimal treatment settings and adjust these treatment settings through the control panel. Furthermore, Magma Spark device, as the cleared Magma device, introduces similar safety features and comply with same relevant consensus standards.

Conclusions:

Based on the comparison to predicate device, Magma Spark device is substantially equivalent to the predicate Magma device for the mentioned indication for use.

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.