# Optimedica Corporation

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 8 (2006–2016): 8 510(k) clearances
- Product codes: OOE (4), GEX (3), HQF (1)
- Predicates its devices cite: 12 (3 its own); citations of its devices by later devices: 16 (3 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Topcon Medical Laser Systems, Inc.: 3 (https://510kreport.com/company/topcon-medical-laser-systems)
- Lumenis, Inc.: 3 (https://510kreport.com/company/lumenis)
- Carl Zeiss, Inc.: 1 (https://510kreport.com/company/carl-zeiss)
- Infinitech, Inc.: 1 (https://510kreport.com/company/infinitech)
- Lensx Lasers, Inc.: 1 (https://510kreport.com/company/lensx-lasers)

## Firms that cite its devices most
- Carl Zeiss Meditec, AG: 4 (https://510kreport.com/company/carl-zeiss-meditec)
- Topcon Medical Laser Systems, Inc.: 3 (https://510kreport.com/company/topcon-medical-laser-systems)
- Quantel Medical: 2 (https://510kreport.com/company/quantel-medical)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)
- Sie Ag,Surgical Instrument Engineering: 1 (https://510kreport.com/company/sie-ag-surgical-instrument-engineering)
- Topcon Medical Laser Systems, Inc. (Tmls): 1 (https://510kreport.com/company/topcon-medical-laser-systems-tmls)
- Abbott Medical Optics, Inc.: 1 (https://510kreport.com/company/abbott-medical-optics)

## Its most-cited devices
- K081744: Pascal Synthesis Delivery System (2008), cited by 4
- K091666: Pascal Photocoagulator, Pascal-US (2009), cited by 3
- K100019: Pascal Streamline Photocoagulator (2010), cited by 3
- K121091: Catalys Precision Laser System (2012), cited by 2
- K062336: Optimedica Laser Indirect Ophthalmoscope (2006), cited by 1
- K161455: Catalys Precision Laser System (2016), cited by 1

## Recent decisions
- K161455: Catalys Precision Laser System (Sep 20, 2016)
- K141079: Optimedica Catalys Precision Laser System (Sep 11, 2014)
- K121091: Catalys Precision Laser System (Aug 28, 2012)
- K113479: Optimedica Catalys Precision Laser System (Dec 21, 2011)
- K100019: Pascal Streamline Photocoagulator (May 4, 2010)
- K091666: Pascal Photocoagulator, Pascal-US (Jul 15, 2009)
- K081744: Pascal Synthesis Delivery System (Sep 9, 2008)
- K062336: Optimedica Laser Indirect Ophthalmoscope (Oct 19, 2006)

Source page: https://510kreport.com/company/optimedica