# K051789: Visante Oct

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Sep 30, 2005 after 91 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
72 later devices descend from it; 4 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) STRATUSOCT with Retinal Nerve Fiber Layer Normative and Macula Database: named in the summary without a submission number
- (no number) Orbscan JJ: named in the summary without a submission number

## Most influential descendants
- K071250: CA, Model: Cam (2007), 64 descendants of its own
- K101505: Rtvue Model Rtvue 100 (2010), 58 descendants of its own
- K083291: Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000 (2009), 29 descendants of its own
- K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES (2012), 24 descendants of its own
- K120238: Rtvue XR Oct (2012), 17 descendants of its own

## Indications for use
The Visante TM OCT is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging and measurement of ocular structures in the anterior segment, such as corneal and LASIK flap thickness.

Source page: https://510kreport.com/device/K051789
Methodology: https://510kreport.com/methodology