# Topcon Medical Laser Systems, Inc.

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 6 (2005–2018): 6 510(k) clearances
- Product codes: HQF (5), GEX (1)
- Predicates its devices cite: 15 (4 its own); citations of its devices by later devices: 21 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Optimedica Corporation: 3 (https://510kreport.com/company/optimedica)
- Iridex Corp: 3 (https://510kreport.com/company/iridex)
- Quantel Medical: 1 (https://510kreport.com/company/quantel-medical)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)
- Ellex Medical Pty, Ltd.: 1 (https://510kreport.com/company/ellex-medical)
- Iriderm Div.: 1 (https://510kreport.com/company/iriderm-div)
- Infinitech, Inc.: 1 (https://510kreport.com/company/infinitech)

## Firms that cite its devices most
- Carl Zeiss Meditec, AG: 4 (https://510kreport.com/company/carl-zeiss-meditec)
- Optimedica Corporation: 3 (https://510kreport.com/company/optimedica)
- Od-Os GmbH: 2 (https://510kreport.com/company/od-os)
- Quantel Medical: 2 (https://510kreport.com/company/quantel-medical)
- Iridex Corp: 2 (https://510kreport.com/company/iridex)
- Topcon Medical Laser Systems, Inc. (Tmls): 2 (https://510kreport.com/company/topcon-medical-laser-systems-tmls)
- Lightmed Corp.: 1 (https://510kreport.com/company/lightmed)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)

## Its most-cited devices
- K111108: Pascal Streamline 577 (with Accessories) (2011), cited by 7
- K043486: Pascal Photocoagulator, Product-Pascal-01 (2005), cited by 6
- K092621: Pascal Streamline Photocoagulator (2009), cited by 4
- K123542: Pascal Synthesis (532NM/577NM) Opthalmic Laser (2013), cited by 3
- K171488: PSLT for PASCAL Streamline (2017), cited by 1

## Recent decisions
- K180402: PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar (May 25, 2018)
- K171488: PSLT for PASCAL Streamline (Nov 27, 2017)
- K123542: Pascal Synthesis (532NM/577NM) Opthalmic Laser (May 15, 2013)
- K111108: Pascal Streamline 577 (with Accessories) (Aug 11, 2011)
- K092621: Pascal Streamline Photocoagulator (Sep 25, 2009)
- K043486: Pascal Photocoagulator, Product-Pascal-01 (Mar 3, 2005)

Source page: https://510kreport.com/company/topcon-medical-laser-systems