# K153566: Magma System

- Pathway: 510(k) (Traditional)
- Applicant: Formatk Systems, Ltd.
- Decided: Apr 6, 2016 after 114 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: 19 generations back to K910422 (1992). 324 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 327 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151947: LightSheer Desire Light Laser System, Lumenis, Ltd. (2015) Summary page 5.
- K142860: Lumenis M22 System, Lumenis, Ltd. (2015) Summary page 5.

## Most influential descendants
- K183307: Magma Spark Pro (Magma Spark Plus, Alpha) (2018), 0 descendants of its own
- K162781: Magma Spark (2016), 0 descendants of its own

## Indications for use
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:YAG Laser Handpiece (ND) with a wavelength of 1064 nm (Multi-Spot Nd:YAGQG) 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.

Source page: https://510kreport.com/device/K153566
Methodology: https://510kreport.com/methodology