(13 days)
Not Found
No
The summary describes a laser and IPL system with various handpieces and a control panel. There is no mention of AI or ML in the intended use, device description, or performance studies. The device relies on operator input and a melanin meter for skin type determination, not automated analysis.
No.
The intended use and indications for use primarily list cosmetic and aesthetic treatments, such as hair removal, reduction of benign epidermal and cutaneous vascular lesions, and treatment of mild to moderate inflammatory acne. While these address certain medical conditions, the overall framing and listed applications fall more under aesthetic enhancement rather than diagnosis, cure, mitigation, treatment, or prevention of disease in a broad therapeutic sense.
No
The device is intended for non-invasive aesthetic and cosmetic treatments, and provides laser and intense pulsed light optical energies for dermatological procedures. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines a physical system including a power supply, CPU board, laser driver board, charging board, simmer board, LCD display, wires, connectors, control components, footswitch panel, water-based cooling system, and a touch screen module, in addition to the software.
Based on the provided information, the Magma Spark Pro system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The stated intended use is for "non-invasive aesthetic and cosmetic treatments." This clearly indicates a therapeutic or cosmetic purpose, not a diagnostic one.
- Indications for Use: All listed indications relate to treating conditions on the skin (hair removal, benign epidermal lesions, vascular lesions, acne, warts, scars, striae). These are all external treatments and do not involve analyzing samples from the body to diagnose a disease or condition.
- Device Description: The description details a system that delivers laser and IPL energy to the skin. It mentions a melanin meter as an accessory for skin type determination, which is a tool to guide treatment parameters, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Magma Spark Pro system operates in vivo (on the body) for aesthetic and therapeutic purposes.
N/A
Intended Use / Indications for Use
The Magma Spark Pro system intended use is for non-invasive aesthetic and cosmetic treatments.
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.
Product codes
GEX, ONF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, hair follicles, epidermal lesions, cutaneous vascular lesions, leg veins, face, truncal area, legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical (Bench) Performance Data:
The underlying technology and principle of operation of Magma Spark Pro is essentially the same as the predicate device. 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. Comprehensive software-system test plan and results report covers the full system test of the Magma Spark Pro. 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
Indications for Use
Device Name Magma Spark Pro
Indications for Use (Describe)
The Magma Spark Pro system intended use is for non-invasive aesthetic and cosmetic treatments.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
3
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.This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Section 6:
Special 510(k) Summary
5
510(K) SUMMARY
MAGMA SPARK PRO DEVICE
510(k) Number K183307
Applicant Name:
| Company Name: | Formatk Systems Ltd. |
|---|---|
| Address: | 3 Hayozma St. |
| Tirat Hacarmel, 3903203, Israel | |
| Tel: +972-4-8571848 | |
| Fax: +972-4-8570810 | |
| E-mail: amit@asteinrac.com |
Contact Person:
| Official Correspondent: | Amit Goren |
|---|---|
| Company Name: | A. Stein – Regulatory Affairs Consulting Ltd. |
| Address: | 20 Hata'as Str., Suite 102 |
| Kfar Saba 4442520 Israel | |
| Tel: + 972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: amit@asteinrac.com | |
| Date Prepared: | December 09, 2018 |
| Trade Name: | Magma Spark Pro (Additional proprietary names: Magma |
| Spark Plus / Alpha) | |
| Classification Name: | 21 CFR Classification section 878.4810 |
| Product Code & | |
| Common Names: | GEX - Powered Laser Surgical Instrument, |
| ONF - Powered Light Based Non-Laser Surgical Instrument | |
| with Thermal Effect | |
| Classification: | Class II Medical Device |
Predicate Device:
The Magma Spark Pro device is substantially equivalent to the previously cleared, Magma device, also manufactured by Formatk Systems Ltd and the subject of 510(k)
6
document K153566. Additional features of the Magma Spark Pro System are substantially equivalent to the Lumenis M22 & ResurFx (manufactured by Lumenis Ltd. and the subject of 510(k) document K170060).
| Device name | Manufacturer | 510(k) No. |
|---|---|---|
| Magma | Formatk Systems Ltd. | K153566 |
| M22 & ResurFX Systems | Lumenis Ltd. | K170060 |
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.
| Main Line Frequency (nominal) | 50 - 60 Hz |
|---|---|
| Input Voltage (nominal) | 100 - 240 VAC |
| Input Current (A) | Max. 7.8A |
| Platform dimensions (inch) | 24.8"W×21.7"D×21.7"H |
| Platform weight (lb.) | 50.7lbs. |
| Platform dimensions + Cart (inch) | 24.8"W×21.7"D×43.4"H |
| Platform + Cart weight (1b.) | 84.5lbs. |
| ALD & LLD Diode laser wavelength (nm) | 808 |
| IPL Applicators wavelength: | |
| S-430 Applicator wavelength (nm) | 430-1100 |
| S-530 Applicator wavelength (nm) | 530-1100 |
| L-530 Applicator wavelength (nm) | 530-1100 |
| S-590 Applicator wavelength (nm) | 590-1100 |
| L-650 Applicator wavelength (nm) | 650-1100 |
Device Specifications:
7
| Maximal Fluence (J/cm²): | |
|---|---|
| ALD | Up to 75 |
| LLD | Up to 28 |
| S-430 Applicator | Up to 45J/cm² |
| S-530 Applicator | Up to 45J/cm² |
| L-530 Applicator | Up to 35J/cm² |
| S-590 Applicator | Up to 45J/cm² |
| L-650 Applicator | Up to 35J/cm² |
Intended Use/Indication for Use:
The Magma Spark Pro system intended use is for non-invasive aesthetic and cosmetic treatments.
The Magma Spark Pro system has connection capability with the following available treatment hand pieces, for multi-application 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:
- Hair removal o
- Permanent hair reduction * in skin type I-VI O
- Pseudofolliculitis Barbae (PFB) O
- · Magma Spark Pro system with Intense Pulsed Light (IPL) Hand pieces (5 different Applicators) with a spectrum of 430-1100nm is intended for:
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, O 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, O or permanent hair reduction * in skin types I-IV through selective targeting of melanin in hair follicles.
8
- Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma о and ephelides (freckles)
- Benign cutaneous vascular lesions, including port wine stains, hemangiomas, o facial truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, venous malformations.
Magma Spark Pro system with L-530 (530-1100nm) IPL hand piece is indicated for:
- o Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles)
- Cutaneous lesions, including warts, scars and striae o
- Benign cutaneous vascular lesions, including port wine stains, hemangiomas, O facial truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
Magma Spark Pro system with S-530 (530-1100nm) IPL hand piece is indicated for:
- Mild to moderate inflammatory Acne (Acne vulgaris) o
- Benign epidermal lesions, including dyschromia, hyperpigmentation, O ephelides (freckles)
- Cutaneous lesions, including warts, scars and striae o
- Benign cutaneous vascular lesions, including port wine stains, hemangiomas, O facial truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
Magma Spark Pro system with S-430 (430-1100nm) IPL hand piece is indicated for:
- Mild to moderate inflammatory Acne (Acne vulgaris) O
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.
9
Performance Standards:
Magma Spark Pro complies with the following FDA recognized consensus standards:
- · IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (2005 +Am.1 2012, 3rd Ed.).
- · IEC 60601-1-2 Medical electrical equipment Part 1-2: Collateral Standard: Electromagnetic compatibility -Requirements and tests (2014, 4th Ed.).
- IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General requirements for safety - Collateral Standard: Usability (2010 + A1:2013, Ed. 3.1).
- IEC 60601-2-22 Medical Electrical Equipment Part 2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (2007, 3rd Ed. + A1:2012).
- IEC 60601-2-57 Medical Electrical Equipment Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (2011, 1st Ed.).
- · IEC 60825-1 Safety of laser products Part 1: Equipment classification and requirements (2014, 3rd Ed.).
- · IEC 62304 Medical device software: Software life-cycle processes (2006, 1st Ed. + A1:2015).
Non-Clinical (Bench) Performance Data:
The underlying technology and principle of operation of Magma Spark Pro is essentially the same as the predicate device. 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. Comprehensive software-system test plan and results report covers the full system test of the Magma Spark Pro. 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
10
Substantial Equivalence:
The below table summarizes the main comparison aspects between the Magma Spark Pro and its proposed predicate devices; the Magma device (FDA cleared in K153566) and M22 & ResurFx Systems (FDA cleared in K170060).
| | Magma Spark
Pro
(modified device;
Formatk Systems
Ltd.) | Magma
K153566
(cleared device;
Formatk Systems
Ltd.) | M22 & ResurFX
Systems
K170060
(reference device;
Lumenis Ltd.) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | | | |
| Product Code | GEX, ONF | GEX, ONF | GEX, ONF, ONG |
| Class | Class II | Class II | Class II |
| Device Technological Characteristics | | | |
| Energy Used / Delivered | • Intense Pulsed
Light (IPL; 430-
1100nm)
• Diode laser
(808nm nominal) | • Intense Pulsed
Light (IPL; 430-
1100nm)
• Diode laser
(808nm nominal)
• Nd:YAG laser
(1064nm) | • Intense Pulsed
Light (IPL; 400-
1200nm) |
| Main Unit and Controller | | | |
| Performance
specifications | Input power: 100-
240V, 50-60Hz
7.8A max. | Input power: 100-
240V, 50-60Hz
9.5A max. | Input power: 100-
240V, 50/60 Hz,
15A max. |
| Physical specifications | Dimensions:
63cmW×55cmD×55
cmH
[24.8"W×21.7"D
×21.7"H]
Weight: 27 Kg
(50.7lbs.)
Magma Spark Pro
(+ Cart):
63cmW×55cmD×11
0cmH
[24.8"W×21.7"D
×43.4"H]
Weight: 45kg
(84.5lbs.) | Dimensions:
40cmW×53cmD×11
9cmH
[15.9"W×21"D
×47.2"H]
Weight: 34 Kg
(74.8lbs.) | Dimensions:
40cmW x 40cmD x
100cmH
[16"Wx16"D
x39"H]
Weight: 75 Kg (165
lbs.) |
| Diode Laser Applicators | | | |
| | Magma Spark
Pro
(modified device;
Formatk Systems
Ltd.) | Magma
K153566
(cleared device;
Formatk Systems
Ltd.) | M22 & ResurFX
Systems
K170060
(reference device;
Lumenis Ltd.) |
| Performance
specifications | ALD Applicator:
• Nominal
wavelength:
808nm
• Tip size:
10×12mm
• Fluence: Up to
75J/cm²
• Pulse duration: 8
to 400msec
• Pulse repetition
rate: up to 10Hz
LLD Applicator:
• Nominal
wavelength:
808nm
• Tip size:
30×15mm
• Fluence: Up to
28J/cm²
• Pulse duration:
25 to 400msec
• Pulse repetition
rate: up to 3Hz | ALD Applicator:
• Nominal
wavelength:
808nm
• Tip size:
10×12mm
• Fluence: Up to
75J/cm²
• Pulse duration: 8
to 400msec
• Pulse repetition
rate: up to 10Hz
LLD Applicator:
• Nominal
wavelength:
808nm
• Tip size:
30×15mm
• Fluence: Up to
35J/cm²
• Pulse duration:
25 to 400msec
• Pulse repetition
rate: up to 4Hz | |
| Physical specifications | ALD
Weight:
1.5kg (3.3lb)
LLD
1.5kg (3.3lb) | ALD
Weight:
1.5kg (3.3lb)
LLD
1.5kg (3.3lb) | |
| Intense Pulsed Light (IPL) Applicators | | | |
| Performance
specifications and
Operation Parameters | S-430 Applicator
Wavelength
spectrum: 430-
1100nm
Tip Size: 2cm²
Fluence: Up to
45J/cm²
Pulse duration: max
50msec | F-AC Applicator
Wavelength
spectrum: 430-
1100nm
Tip size: 1.6 cm²
Fluence: Up to
21.8J/cm²
Pulse duration: max
6msec | The Universal IPL
hand piece has ten
(10) different filters
available:
Cut-off filters of
515,560, 590,615,
640, 695 and 755
nm, |
| Magma Spark
Pro
(modified device;
Formatk Systems
Ltd.) | Magma
K153566
(cleared device;
Formatk Systems
Ltd.) | M22 & ResurFX
Systems
K170060
(reference device;
Lumenis Ltd.) | |
| S-530 Applicator
Wavelength
spectrum: 530-
1100nm
Tip Size: 2cm²
Fluence: Up to
45J/cm²
Pulse duration max
50msec
L-530 Applicator
Wavelength
spectrum: 530-
1100nm
Tip Size: 5cm²
Fluence: Up to
35J/cm²
Pulse duration: max
50msec
N/A | F-SR Applicator
Wavelength
spectrum: 530-
1100nm
Tip size: 1.6 cm²
Fluence: Up to
21.8J/cm²
Pulse duration: max
6msec
SR Applicator
Wavelength
spectrum: 530-
1100nm
Tip size: 6.5 cm²
Fluence: Up to
21.8J/cm²
Pulse duration: max
55msec
B-SR Applicator | Notch Filters of
400-600 & 800-
1200 nm and
530-650 & 900-
1200 nm and a
Narrow band filter
of 525-585 nm.
Max Fluence: Up to
35 or 56 J/cm²,
upon tip size.
The higher 56J/cm²
is supported by
Lumenis 510(k)
number K020839. | |
| S-590 Applicator
Wavelength
spectrum: 590-
1100nm
Tip Size: 2cm²
Fluence: Up to
45J/cm²
Pulse duration: max
50msec | F-HR Applicator
Wavelength
spectrum: 590-
1100nm
Tip size: 1.6 cm²
Fluence: Up to
20.2J/cm²
Pulse duration: max
6msec | | |
| N/A
N/A
L-650 Applicator
Wavelength
spectrum: 650-
1100nm
Tip Size: 5cm²
Fluence: Up to
351/cm² | HR Applicator
B-HR Applicator
HR* Applicator
Wavelength
spectrum: 650-
1100nm
Tip size: 6.5 cm²
Fluence: Up to
19J/cm² | | |
| | Magma Spark
Pro | Magma
K153566 | M22 & ResurFX
Systems
K170060 |
| | (modified device;
Formatk Systems
Ltd.) | (cleared device;
Formatk Systems
Ltd.) | (reference device;
Lumenis Ltd.) |
| | Pulse duration: max
50msec | Pulse duration: max
55msec | |
| | N/A
N/A | F-HR* Applicator
B-HR*Applicator | |
| Physical specifications | Weight: 1.6Kg
Cord length:1.6m | Weight: 1.6Kg
Cord length:1.6m | |
| Safety and adherence to standards | | | |
| Standards Met | • IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-22
• IEC 60601-2-57
• IEC 60825-1 | • IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-22
• IEC 60601-2-57
• IEC 60825-1 | • IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-57 |
11
12
13
The components of modified Magma Spark Pro device, similarly to predicate Magma device, generate its mechanism of operation using the same underlying technology. Delivery of the laser energy and IPL energies through each specific applicator (either Laser or IPL) is monitored and controlled by the device's CPU. The user interface control panel provides the user with the optimal treatment settings taking into consideration the patient skin type and hair type (for hair removal treatments). Similarly to the cleared device, the Magma Spark Pro device user can decide on the optimal treatment settings and adjust these treatment settings through the control panel. Furthermore, Magma Spark Pro device, as the cleared Magma device, introduces similar safety features and comply with same relevant consensus standards. Minor differences are obtained in the hand pieces performance specifications (Max. fluence, tip size). These differences do not pose any new risks related to the device functionality and patient safety and do not alter the device safety and effectiveness.
Conclusions:
Based on the performance testing and comparison to predicate devices, the modified Magma Spark Pro device is found substantially equivalent to its cleared device for the mentioned indications for use and can be legally marketed in the USA.