# K162781: Magma Spark

- Pathway: 510(k) (Special)
- Applicant: Formatk Systems, Ltd.
- Decided: Nov 9, 2016 after 37 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). 325 ancestors in all.
No later device cites it as a predicate yet.
0 of 326 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 4.

## Indications for use
Magma Spark device is indicated for use in aesthetic and cosmetic applications in dermatology. Magma Spark device has connection capability with the following available treatment hand-pieces (applicators), for multi-application treatment options. All hand-pieces are designed for aesthetic and cosmetic dermatologic procedure applications. Magma Spark device with ALD or LLD diode laser applicators is indicated for hair removal, permanent hair reduction* in skin types I-VI and for the treatment of pseudofolliculitis barbae (PFB). (*Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after completion of treatment regime)

Source page: https://510kreport.com/device/K162781
Methodology: https://510kreport.com/methodology