# Formatk Systems, Ltd.

- Location (FDA's records): Tirat Carmel, IL
- FDA decisions: 4 (2016–2018): 4 510(k) clearances
- Product codes: GEX (3), ONF (1)
- 510(k) review time since 2016: median 58 days, against 101 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 7 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lumenis, Inc.: 4 (https://510kreport.com/company/lumenis)
- Viora, Ltd.: 1 (https://510kreport.com/company/viora)

## Its most-cited devices
- K153566: Magma System (2016), cited by 2

## Recent decisions
- K183307: Magma Spark Pro (Magma Spark Plus, Alpha) (Dec 11, 2018)
- K162781: Magma Spark (Nov 9, 2016)
- K160195: Forma System, Forma Light System (Apr 15, 2016)
- K153566: Magma System (Apr 6, 2016)

Source page: https://510kreport.com/company/formatk-systems