Manufacturer
Formatk Systems , Ltd.Magma Spark Pro (Magma Spark Plus, Alpha)
Country / Region:Israel (IL)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K183307
- Device name
- Magma Spark Pro (Magma Spark Plus, Alpha)
- Company
- Formatk Systems , Ltd.
- Country / Region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-11-28
- Decision date
- 2018-12-11
- Submission type
- Special
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
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 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: 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: Magma Spark Pro system with L-650 (650-1100nm) IPL hand piece is indicated for: o 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. o Benign epidermal lesions, including dyschromia, hyperpigmentation Magma Spark Pro system with S-590 (590-1100nm) IPL hand piece is indicated for: o Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction * in skin types I-IV through selective targeting of melanin in hair follicles. o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles) o 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. Magma Spark Pro system with L-530 (530-1100nm) IPL hand piece is indicated for: o Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles) o Cutaneous lesions, including warts, scars and striae o 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. Magma Spark Pro system with S-530 (530-1100nm) IPL hand piece is indicated for: o Mild to moderate inflammatory Acne (Acne vulgaris) o Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles) o Cutaneous lesions, including warts, scars and striae o 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 Magma Spark Pro system with S-430 (430-1100nm) IPL hand piece is indicated for: o 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.
Intended 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: 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: Magma Spark Pro system with L-650 (650-1100nm) IPL hand piece is indicated for: o 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. o Benign epidermal lesions, including dyschromia, hyperpigmentation
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 non-invasive 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.
Summary parsed at:2026-06-01 05:58:08 UTC
Predicate devices
3—
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Not ingested
Magma System
M22 and ResurFx Systems
K183307 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K183307 as a predicate
