The Magma System has connection capability with the following available treatment handpieces, for multi application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:

The Magma System with ALD/LLD Laser Handpiece is indicated for hair removal, permanent hair reduction* in skin types I-VI and for the treatment of Pseudofolliculitis Barbae (PFB).
The Magma System with Nd: Y AG Laser Handpiece (ND) with a wavelength of 1064 nm (Multi-Spot Nd: Y AG) is indicated for:

· The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg

· The 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.

• The non-ablative treatment of facial wrinkles

The Magma System with the Intense Pulsed Light (IPL) Handpieces (10 different Applicators) with a spectrum of 430-1100nm is indicated for:

HR*, F-HR*, B-HR* Applicators (650-1100nm):

· 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.

HR, F-HR, B-HR Applicators (590-1100nm):

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

SR, F-SR, B-SR Applicators (530-1100nm):

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

· Cutaneous lesions, including 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. F-AC Applicator (430-1100nm):

T-AC Applicator (+50-1100mm).

· 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 System is a computerized multi-application, multi-technology platform, intended for non-invasive aesthetic applications utilizing laser and Intense Pulsed Light (IPL) optical power.

The system platform includes AC/DC power supply unit, water based cooling system, CPU main card and user interface including a LCD display and touch screen module. Apart from the system platform the Magma System is provided with 13 applicators divided into three technology related sub-categories:

ALD & LLD Diode laser (808nm) Applicators for hair removal treatments.
Multi-spot Nd:YAG laser (1064nm) Applicator for coagulation and hemostasis of vascular lesions and soft tissue, hair removal treatments and non-ablative treatment of facial wrinkles.
Ten Intense Pulsed Light (IPL) Applicators divided into four sub-categories:
- o HR*, F-HR* & B-HR* (650-1100nm) Applicators for hair removal treatments (skin types I-V).
- o HR, F-HR & B-HR (590-1100nm) Applicators for hair removal treatments (skin types I-IV).
- o SR. F-SR & B-SR (530-1100mm) Applicators for the treatment of pigmented and vascular lesions.
- o F-AC (430-1100nm) Applicator for acne treatments.

The operator chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the Magma System. The Magma System has two applicator ports; one for IPL based applicators and one for Laser applicators. The ports must be simultaneously connected with both laser and IPL applicators for the system to operate.

AI/ML Overview

The provided text is a 510(k) summary for the Magma System, a multi-application aesthetic device utilizing laser and Intense Pulsed Light (IPL) technology. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report for novel performance claims.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific percentages for hair reduction, lesion clearance). Instead, it relies on demonstrating that its design and components are similar to already cleared predicate devices and that its functionality and mechanism of operation are similar.

Reported Device Performance (based on similarity to predicate devices and general claims):

Hair Removal/Permanent Hair Reduction:
- ALD/LLD Laser Handpiece: Skin types I-VI.
- Nd:YAG Laser Handpiece: Skin types I-V.
- IPL HR*, F-HR*, B-HR* (650-1100nm) Applicators: Skin types I-V.
- IPL HR, F-HR, B-HR (590-1100nm) Applicators: Skin types I-IV.
- Note: Permanent hair reduction defined as long-term, stable reduction measured at 6, 9, and 12 months post-treatment.
Vascular Lesions/Soft Tissue Coagulation and Hemostasis:
- Nd:YAG Laser Handpiece: Superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
Non-ablative treatment of facial wrinkles:
- Nd:YAG Laser Handpiece.
Benign Epidermal Lesions:
- IPL SR, F-SR, B-SR (530-1100nm) Applicators: Dyschromia, hyperpigmentation, ephelides (freckles).
Cutaneous Lesions:
- IPL SR, F-SR, B-SR (530-1100nm) Applicators: Striae.
Benign Cutaneous Vascular Lesions:
- IPL SR, F-SR, B-SR (530-1100nm) Applicators: Port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
Mild to moderate inflammatory Acne (Acne vulgaris):
- IPL F-AC Applicator (430-1100nm).

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

The document explicitly states: "Clinical Performance Data: Not Applicable". This indicates that a separate clinical study with a test set was not conducted or presented for this 510(k) submission. The submission relies on establishing substantial equivalence to predicate devices which have already demonstrated clinical effectiveness.

Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not provided.

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

Not applicable, as no clinical test set with human-established ground truth was presented.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was presented.

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 Magma System is an aesthetic laser/IPL device for direct treatment, not an AI-based diagnostic tool 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. The Magma System is a physical medical device (laser/IPL system) operated by a human, not a standalone algorithm.

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

Not applicable for a clinical performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior clearances and the scientific literature supporting the principles of laser and IPL technology for the stated indications.

8. The sample size for the training set:

Not applicable. The document describes a medical device, not an AI algorithm requiring a training set in the conventional sense. The "training" for such a device would be the extensive research and development in laser and IPL technology, manufacturing, and engineering specific to the device's design, which is validated through non-clinical performance tests.

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

Not applicable. As above, this is not an AI algorithm submission with a distinct training set and ground truth establishment methodology. The "ground truth" for the device's functionality is demonstrated through compliance with recognized consensus standards (e.g., AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, IEC 60601-2-57) and non-clinical performance tests verifying hardware and software functionality and safety. The clinical efficacy is substantially equivalent to predicate devices.

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

April 6, 2016

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

Re: K153566

Trade/Device Name: Magma System 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: March 3, 2016 Received: March 7, 2016

Dear Ms. 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 yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153566

Device Name Magma System

Indications for Use (Describe)

The Magma System is indicated for use in aesthetic applications in dermatology.

The Magma System with ALD/LLD Laser Handpiece is indicated for hair removal, permanent hair reduction* in skin types I-VI and for the treatment of Pseudofolliculitis Barbae (PFB).
The Magma System with Nd: Y AG Laser Handpiece (ND) with a wavelength of 1064 nm (Multi-Spot Nd: Y AG) is indicated for:

· The 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.

• The non-ablative treatment of facial wrinkles

The Magma System with the Intense Pulsed Light (IPL) Handpieces (10 different Applicators) with a spectrum of 430-1100nm is indicated for:

HR*, F-HR*, B-HR* Applicators (650-1100nm):

· 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.

HR, F-HR, B-HR Applicators (590-1100nm):

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

SR, F-SR, B-SR Applicators (530-1100nm):

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

· Cutaneous lesions, including striae

T-AC Applicator (+50-1100mm).

· 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY

MAGMA SYSTEM

510(k) Number K153566

Applicant Name:

Company Name:	Formatek Systems Ltd.
Address:	3 Hayozma St.Tirat Hacarmel, 3903203, Israel
Tel:	+972-4-8571848
Fax:	+972-4-8570810
E-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 4442500Israel
Tel:	+972-9-7670002
Fax:	+972-9-7668534
E-mail:	ahava@asteinrac.com
Date Prepared:	April 06, 2016
Trade Name:	Magma System
Classification Name:	CFR Classification section 878.4810;(Product codes GEX and ONF)
Classification:	Class II Medical Device

Predicate Device:

The Magma System is substantially equivalent to the following predicate devices:

Manufacturer	Device	510(k) No.
Lumenis Ltd.	LightSheer Desire Light Laser System	K151947
Lumenis Ltd.	Lumenis M22 System	K142860

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Device Description:

The Magma System is a computerized multi-application, multi-technology platform, intended for non-invasive aesthetic applications utilizing laser and Intense Pulsed Light (IPL) optical power.

ALD & LLD Diode laser (808nm) Applicators for hair removal treatments.
Multi-spot Nd:YAG laser (1064nm) Applicator for coagulation and hemostasis of vascular lesions and soft tissue, hair removal treatments and non-ablative treatment of facial wrinkles.
Ten Intense Pulsed Light (IPL) Applicators divided into four sub-categories:
- o HR*, F-HR* & B-HR* (650-1100nm) Applicators for hair removal treatments (skin types I-V).
- o HR, F-HR & B-HR (590-1100nm) Applicators for hair removal treatments (skin types I-IV).
- o SR. F-SR & B-SR (530-1100mm) Applicators for the treatment of pigmented and vascular lesions.
- o F-AC (430-1100nm) Applicator for acne treatments.

Device Specifications:

Main Line Frequency (nominal)	50 - 60 Hz
Input Voltage (nominal)	100-240 VAC
Input Current	4.0-9.5 A
Platform dimensions	15.9"Wx21"Dx47.2"H
Platform weight	74.8 [lb]
ALD & LLD Diode laser wavelength	808nm
Nd:YAG laser wavelength	1064nm
IPL wavelength	430-1100nm
Maximal Fluence (J/cm²):
ALD	Up to 75
LLD	Up to 35

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HR, F-HR & B-HR*	Up to 19
HR, F-HR & B-HR	Up to 20.2
SR, F-SR & B-SR	Up to 21.8
F-AC	Up to 21.8

Intended Use/Indication for Use:

The Magma System is indicated for use in surgical, aesthetic applications in the medical specialties of general and plastic surgery, and dermatology.

The Magma System has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:

1. The Magma System with ALD/LLD Laser Handpiece is indicated for hair removal, permanent hair reduction* in skin types I-VI and for the treatment of Pseudofolliculitis Barbae (PFB).

The Magma System with Nd: YAG Laser Handpiece (ND) with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for:

· The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg.
· The 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.
· The non-ablative treatment of facial wrinkles.

The Magma System with the Intense Pulsed Light (IPL) Handpieces (10 different Applicators) with a spectrum of 430-1100nm is indicated for:

HR, F-HR, B-HR* Applicators (650-1100nm):

· 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.

HR, F-HR, B-HR Applicators (590-1100nm):

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

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SR, F-SR, B-SR Applicators (530-1100nm):

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

F-AC Applicator (430-1100nm):

· 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.

Performance Standards:

The Magma System complies with the recognized consensus standards listed below:

· 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 [Including: 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.
· IEC 60601-2-57 (Edition 2.0, 2011), 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.

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Non-Clinical Performance Data:

A set of performance tests was conducted on the Magma System to evaluate the system's safety and effectiveness and to verify that the Magma System adhere to all of the design requirement specifications.

The comprehensive software-system test plan and results report covers the full system test of the Magma System. 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.

Clinical Performance Data:

Not Applicable

Substantial Equivalence:

The indications for use and technological characteristics of the Magma System are substantially equivalent to the indications for use and technological characteristics of the suggested predicate devices - the LightSheer Desire Light Laser and the Lumenis M22 Systems.

The design and components in the Magma System, including the power inlet unit, CPU controller, laser and IPL units and display panel are similar to the design and components found in the predicate devices. The Magma System Applicators possess similar technological principals to the predicate devices Applicators of diode laser, Nd:YAG laser and IPL energy delivery systems. Although there are some noticeable differences between the Magma System and the predicate devices technological characteristics and system specifications the Magma System effectiveness and safety is maintained due to the similar functionality and mechanism of operation. Both devices present similar performance specifications (for the specified indication for use) and similar monitoring features in order to maintain the desired power output settings. The safety features and compliance with safety standards in the Magma System are similar to the safety features and compliance with safety standards found in the predicate devices. Patient contact materials are also similar. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the Magma System underwent performance testing, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2, safety of laser products according to IEC 60825-1, basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment according to IEC 60601-2-22, and basic safety and essential performance of non-laser light source equipment intended for

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therapeutic, diagnostic, monitoring and cosmetic/aesthetic use according to IEC 60601-2-57 and bench testing to evaluate the consistency of the laser and IPL power output. These performance tests demonstrated that the minor differences in the device design and specifications meet the system requirements and do not raise new safety or effectiveness concerns.

Conclusions:

Consequently, it can be concluded that the Magma System is substantially equivalent to the LightSheer Desire Light Laser System, cleared under 510(k) K151947, and to the Lumenis M22 System, cleared under 510(k) K142860 and therefore, may be legally marketed in the USA.

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.