# Carl Zeiss Meditec, AG

- Location (FDA's records): Dublin, CA
- FDA decisions: 81 (1986–2026): 77 510(k) clearances and 4 original PMA approvals
- Names in FDA's records: Carl Zeiss Meditec, AG (49); Carl Zeiss Meditec, Inc. (31); Carl Zeiss Meditec (1)
- Product codes: NFJ (13), OBO (12), HJO (9), HLI (7), HQF (6), GEX (4), JAD (4), HQC (3), QER (3), GWG (3), MYC (2), QFX (2)
- 510(k) review time since 2016: median 176 days, against 156 for FDA's reviews in the same codes and years (11 of 28 faster)
- Predicates its devices cite: 139 (78 its own); citations of its devices by later devices: 118 (78 its own)
- Recalls linked to its devices: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Intra Lase Corp.: 10 (https://510kreport.com/company/intra-lase)
- Carl Zeiss, Inc.: 6 (https://510kreport.com/company/carl-zeiss)
- Carl Zeiss Surgical GmbH: 5 (https://510kreport.com/company/carl-zeiss-surgical)
- Topcon Medical Laser Systems, Inc.: 4 (https://510kreport.com/company/topcon-medical-laser-systems)
- Optimedica Corporation: 4 (https://510kreport.com/company/optimedica)
- Carl Zeiss Ophthalmic Systems, Inc.: 2 (https://510kreport.com/company/carl-zeiss-ophthalmic-systems)
- Nidek, Inc.: 2 (https://510kreport.com/company/nidek)
- Topcon Corporation: 2 (https://510kreport.com/company/topcon)

## Firms that cite its devices most
- Nidek, Inc.: 3 (https://510kreport.com/company/nidek)
- Heidelberg Engineering GmbH: 3 (https://510kreport.com/company/heidelberg-engineering)
- Optovue, Inc.: 2 (https://510kreport.com/company/optovue)
- Talia Technology, Ltd.: 2 (https://510kreport.com/company/talia-technology)
- Santec Corporation: 2 (https://510kreport.com/company/santec)
- Centervue S.P.A.: 2 (https://510kreport.com/company/centervue)
- Cylite Pty., Ltd.: 2 (https://510kreport.com/company/cylite)
- Sonomed, Inc.: 1 (https://510kreport.com/company/sonomed)

## Its most-cited devices
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match (2012), cited by 11
- K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES (2012), cited by 6
- K030433: Stratusoct with RNFL Normative Database (2003), cited by 5
- K090439: FORUM (2009), cited by 5
- K112184: Cirrus Photo (2012), cited by 5
- K150977: Cirrus HD-Oct (2015), cited by 4

## Recent decisions
- K261361: TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet) (Oct 15, 2026)
- K260694: Zeiss Clinic 360 (Jul 17, 2026)
- K243878: Clarus (700) (Apr 17, 2025)
- K241174: INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) (Jan 10, 2025)
- K233911: VISULAS combi (Sep 6, 2024)
- K240215: Blue 400; Blue 400 S (Jun 28, 2024)
- K233933: CIRRUS™ HD-OCT Model 6000 (May 17, 2024)
- K233421: Rescan 700 (Mar 8, 2024)

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