# Focus Medical, LLC

- Location (FDA's records): Bethel, CT
- FDA decisions: 10 (1997–2016): 10 510(k) clearances
- Names in FDA's records: Focus Medical, LLC (9); Focus Medical SA (1)
- Product codes: GEX (7), KPS (1), GEN (1), ONG (1)
- Predicates its devices cite: 24 (2 its own); citations of its devices by later devices: 6 (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
- Altus Medical, Inc.: 4 (https://510kreport.com/company/altus-medical)
- Laserscope: 4 (https://510kreport.com/company/laserscope)
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Continuum Electro-Optics, Inc.: 2 (https://510kreport.com/company/continuum-electro-optics)
- Quanta System Spa: 1 (https://510kreport.com/company/quanta-system)
- General Electric Co.: 1 (https://510kreport.com/company/general-electric)
- Nuccardiac Software, Inc.: 1 (https://510kreport.com/company/nuccardiac-software)
- Candela Corpation: 1 (https://510kreport.com/company/candela-corpation)

## Firms that cite its devices most
- Alma Lasers, Inc.: 2 (https://510kreport.com/company/alma-lasers)
- Quanta System Spa: 1 (https://510kreport.com/company/quanta-system)
- Sandstone Medical Technologies, LLC: 1 (https://510kreport.com/company/sandstone-medical-technologies)

## Its most-cited devices
- K151473: NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module (2015), cited by 1
- K031828: Naturalase LP ND:Yag Laser (2003), cited by 1
- K041829: Focus Medical Naturalase LP and Naturalight Family of Products (2004), cited by 1
- K032667: Focus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red or Yellow) (2004), cited by 1
- K992597: Lorad LT-100 Laser Treatment System (2000), cited by 1
- K110333: Naturalase CO2 Laser System (2012), cited by 1

## Recent decisions
- K152737: Lite Touch (Jun 29, 2016)
- K152529: NaturaLase CO2 Laser System (Feb 4, 2016)
- K151473: NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module (Sep 1, 2015)
- K110333: Naturalase CO2 Laser System (Apr 12, 2012)
- K101152: Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family Naturalase NL810 (Aug 18, 2010)
- K041829: Focus Medical Naturalase LP and Naturalight Family of Products (Sep 7, 2004)
- K032667: Focus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red or Yellow) (Jan 23, 2004)
- K031828: Naturalase LP ND:Yag Laser (Jul 17, 2003)

Source page: https://510kreport.com/company/focus-medical