# K183307: Magma Spark Pro (Magma Spark Plus, Alpha)

- Pathway: 510(k) (Special)
- Applicant: Formatk Systems, Ltd.
- Decided: Dec 11, 2018 after 13 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K910422 (1992). 326 ancestors in all.
No later device cites it as a predicate yet.
0 of 327 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153566: Magma System, Formatk Systems, Ltd. (2016) Summary page 7.
- K170060: M22 and ResurFx Systems, Lumenis, Ltd. (2017) Summary page 7.

## 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: 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 reduction * 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.

Source page: https://510kreport.com/device/K183307
Methodology: https://510kreport.com/methodology