# K231673: P200TE (A10700)

- Pathway: 510(k) (Traditional)
- Applicant: Optos Plc.
- Decided: Aug 18, 2023 after 71 days
- Product code: OBO (Tomography, Optical Coherence)
- 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
Longest line of descent: 7 generations back to K012727 (2002). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173707: P200TE, Optos Plc. (2018) Summary page 4.
- K121739: Ivue with Normative Database, Optovue, Inc. (2013) Summary page 4.

## Most influential descendants
- K233602: P200TE (A10700) (2024), 0 descendants of its own

## Indications for use
The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and analysis of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc, under mydriatic and non-mydriatic conditions. It is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps. The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.

Source page: https://510kreport.com/device/K231673
Methodology: https://510kreport.com/methodology