The Magma Spark Pro system has connection capability with the following available treatment hand pieces, for multiapplication treatment options. All hand pieces are designed for aesthetic and dermatological skin procedure applications, as follows:

· Magma Spark Pro system with ALD/LLD Laser hand piece is indicated for:

o Hair removal

o Permanent hair reduction * in skin type I-VI
o Pseudofolliculitis Barbae (PFB)

· Magma Spark Pro system with Intense Pulsed Light (IPL) Hand pieces (5 different Applicators) with a spectrum of 430-1100nm is intended for:

o Magma Spark Pro system with L-650 (650-1100nm) IPL hand piece is indicated for:

" Removal of unwanted hair from all skin types, and to effect stable long term. or permanent hair reduction * in skin types

I-V through selective targeting of melanin in hair follicles.

" Benign epidermal lesions, including dyschromia, hyperpigmentation

o Magma Spark Pro system with S-590 (590-1100nm) IPL hand piece is indicated for:

▪ Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair recuction * in skin types I-IV through selective targeting of melanin in hair follicles.

· Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles)

· Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial truncal and leg telangiectasias,

erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, venous malformations.

o Magma Spark Pro system with L-530 (530-1100nm) IPL hand piece is indicated for:

· Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles)

· Cutaneous lesions, including warts, scars and striae
· Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial truncal and leg telangiectasias,

erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

o Magma Spark Pro system with S-530 (530-1100nm) IPL hand piece is indicated for:

· Mild to moderate inflammatory Acne (Acne vulgaris)

· Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles)

· Cutaneous lesions, including warts, scars and striae
· Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations

o Magma Spark Pro system with S-430 (430-1100nm) IPL hand piece is indicated for:

= Mild to moderate inflammatory Acne (Acne vulgaris)

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

Device Description

The Magma Spark Pro device is a computerized, multi-application, compatible system platform designed to provide laser and intense pulsed light (IPL) optical energies for noninvasive aesthetic dermatology procedures.

The Magma Spark Pro is a relatively small tabletop device (portable version is also available). The device is compatible with two diode laser applicators (ALD and LLD) at nominal 808 nm wavelength and five IPL applicators: S-430, S-530, S-590, L-530 and L-650 at a wavelength range of 430-1100 nm. The system platform includes an AC/DC safety approved power supply, a CPU board, a Laser driver board, a charging board, a simmer board, an LCD display, Wires connectors and control components (inlet with On/Off switch and fuses, Emergency button), footswitch panel, water based cooling system for IPL and Laser applicators cooling and a touch screen module. The operator of Magma Spark Pro chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the device. Melanin meter is provided as an accessory tool for skin type determination.

AI/ML Overview

The provided document is a 510(k) summary for the Magma Spark Pro device. It details various aspects of the device, including its intended use, specifications, and comparison to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Instead, the document states: "Therefore, apart to the performance testing conducted in adherence with the aforementioned recognized consensus standards, no additional testing was performed to sustain device safety and effectiveness." and "Clinical Performance Data: Not Applicable."

This implies that the device's safety and effectiveness for its stated indications for use are established through adherence to recognized consensus standards and by demonstrating substantial equivalence to previously cleared predicate devices, rather than through new clinical performance studies with specific acceptance criteria.

Therefore, many of the requested sections about acceptance criteria, clinical studies, sample sizes, ground truth, experts, and adjudication methods are not applicable based on the provided text.

Here's a breakdown of what can be extracted based on the document:

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

No explicit acceptance criteria or reported device performance in terms of clinical outcomes (e.g., hair reduction percentage, lesion clearance rate) are provided. The "performance" discussed in the document refers to technical specifications and adherence to safety standards.

Acceptance Criteria (Explicit Clinical Performance)	Reported Device Performance
Not Applicable (No explicit clinical performance acceptance criteria stated in the document)	Not Applicable (No clinical performance data reported in the document)

The document does mention compliance with several performance standards (e.g., IEC 60601-1 for basic safety, IEC 60825-1 for laser product safety), which are technical and safety-related, not clinical efficacy or diagnostic accuracy criteria.

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

Not applicable, as no clinical performance study with a test set is described.

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 clinical performance study with a test set and ground truth established by experts is described.

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

Not applicable, as no clinical performance study with a 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

Not applicable. The device is a laser/IPL system for aesthetic treatments, not an AI or diagnostic imaging device that would involve human readers or MRMC studies.

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

Not applicable. The device is a physical medical device, not an algorithm.

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

Not applicable, as no clinical performance study requiring ground truth is described. The approval is based on substantial equivalence to predicate devices and adherence to technical safety standards.

8. The sample size for the training set

Not applicable, as no machine learning or AI algorithm requiring a training set is described.

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

Not applicable.

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 & 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.

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

December 11, 2018

Re: K183307

Trade/Device Name: Magma Spark Pro (Magma Spark Plus, Alpha) 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, ONF Dated: November 25, 2018 Received: November 28, 2018

Dear Amit Goren:

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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.

Image /page/1/Picture/5 description: This image shows a digital signature from Neil R.P. Ogden on December 11, 2018 at 08:44:42 -05'00'. The signature is for Binita S. Ashar, who is a Director in the Division of Surgical Devices. She also works in the Office of Device Evaluation and the Center for Devices and Radiological Health.

Enclosure

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Indications for Use

K183307

Device Name Magma Spark Pro

Indications for Use (Describe)

The Magma Spark Pro system intended use is for non-invasive aesthetic and cosmetic treatments.

· Magma Spark Pro system with ALD/LLD Laser hand piece is indicated for:

o Hair removal

o Permanent hair reduction * in skin type I-VI
o Pseudofolliculitis Barbae (PFB)