# K233602: P200TE (A10700)

- Pathway: 510(k) (Traditional)
- Applicant: Optos Plc.
- Decided: May 9, 2024 after 182 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: 8 generations back to K012727 (2002). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121739: Ivue with Normative Database, Optovue, Inc. (2013) Summary page 5.
- K231673: P200TE (A10700), Optos Plc. (2023) Summary page 5.

## 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 measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc under mydriatic and nonmydriatic conditions. P200TE 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 includes a Reference Database that enables the results of OCT segmentation analysis to be compared to reference data, including Full retinal thickness, Ganglion Cell Complex thickness, Retina Nerve Fiber Layer thickness and Optic Nerve Head metrics. 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/K233602
Methodology: https://510kreport.com/methodology