# Carl Zeiss, Inc.

- Location (FDA's records): Thornwood, NY
- FDA decisions: 44 (1980–2001): 44 510(k) clearances
- Product codes: GEX (17), HJO (4), EPT (3), FSH (2), HQF (2), HLI (2), HPL (1), HAW (1), GCJ (1), HRM (1), GCT (1), HET (1)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 33 (3 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sharplan Lasers, Inc.: 1 (https://510kreport.com/company/sharplan-lasers)
- Premier Laser Systems, Inc.: 1 (https://510kreport.com/company/premier-laser-systems)
- Biovision, Inc.: 1 (https://510kreport.com/company/biovision)
- Zeiss Humphrey System: 1 (https://510kreport.com/company/zeiss-humphrey-system)
- Iriderm Div.: 1 (https://510kreport.com/company/iriderm-div)

## Firms that cite its devices most
- Carl Zeiss Meditec, AG: 6 (https://510kreport.com/company/carl-zeiss-meditec)
- Philips Medical Systems, Inc.: 3 (https://510kreport.com/company/philips-medical-systems)
- Pentax Medical Company: 2 (https://510kreport.com/company/pentax-medical)
- Meridian AG: 2 (https://510kreport.com/company/meridian)
- Oktas: 2 (https://510kreport.com/company/oktas)
- Vista Medical Technologies, Inc.: 2 (https://510kreport.com/company/vista-medical-technologies)
- New Star Lasers, Inc.: 2 (https://510kreport.com/company/new-star-lasers)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)

## Its most-cited devices
- K013402: Visulas 532S (2001), cited by 5
- K965139: Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) System (1997), cited by 4
- K954167: Humphrey Field Analyzer (Hfa II) (1995), cited by 4
- K950985: Zeiss Endolive Stero Endoscope (1995), cited by 3
- K993357: Iolmaster (2000), cited by 3
- K912581: Zeiss Confocal Laser Scanning Ophthalmoscope (Clso) (1991), cited by 2

## Recent decisions
- K013402: Visulas 532S (Nov 14, 2001)
- K003885: Visulas Yag II (Feb 22, 2001)
- K993357: Iolmaster (Mar 20, 2000)
- K983868: Opmi Twiner Surgical Microscope (Jan 29, 1999)
- K965139: Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) System (Apr 23, 1997)
- K961380: CPC Probe (Mar 17, 1997)
- K961171: Humphrey Oct Scanner (Jun 21, 1996)
- K954167: Humphrey Field Analyzer (Hfa II) (Nov 24, 1995)

Source page: https://510kreport.com/company/carl-zeiss