Magma System
Device Facts
| Record ID | K153566 |
|---|---|
| Device Name | Magma System |
| Applicant | Formatk Systems , Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Apr 6, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications 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). 2. 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. 3. 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): 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 Story
Multi-application platform utilizing laser (808nm diode, 1064nm Nd:YAG) and IPL (430-1100nm) energy; used in dermatology/plastic surgery clinics. System comprises power supply, water-based cooling, CPU, and touch-screen interface. Operator selects treatment mode/intensity via digital panel; requires simultaneous connection of laser and IPL handpieces for operation. Energy delivery targets melanin in hair follicles, vascular structures, or skin tissue to achieve therapeutic effects (hair reduction, coagulation, wrinkle reduction, acne treatment). Output is controlled optical energy; healthcare provider monitors delivery via interface. Benefits include non-invasive aesthetic skin improvements.
Clinical Evidence
No clinical data. Bench testing only, including software validation, electrical/mechanical safety, electromagnetic compatibility, laser safety, and power output consistency verification.
Technological Characteristics
Multi-technology platform; 808nm diode, 1064nm Nd:YAG, 430-1100nm IPL. Water-based cooling. 100-240 VAC input. Compliance: AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, IEC 60601-2-57. Touch-screen interface. Two applicator ports (laser/IPL).
Indications for Use
Indicated for aesthetic/dermatological procedures including hair removal/reduction (skin types I-VI), treatment of Pseudofolliculitis Barbae, coagulation/hemostasis of vascular lesions (0.1-4.0mm), non-ablative facial wrinkle treatment, benign epidermal/vascular lesion treatment, and mild-to-moderate inflammatory acne.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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 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).
2. 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
3. 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.
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)
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# 510(K) SUMMARY
# MAGMA SYSTEM
# 510(k) Number K153566
# Applicant Name:
| Company Name: | Formatek Systems Ltd. |
|---------------|--------------------------------------------------|
| Address: | 3 Hayozma St.<br>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 102<br>Kfar Saba 4442500<br>Israel |
| 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;<br>(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.
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.
# 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).
2. 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.
3. 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.
