# K121043: Optos Oct/Slo Microperimeter

- Pathway: 510(k) (Traditional)
- Applicant: Optos Plc.
- Decided: Feb 22, 2013 after 323 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: 4 generations back to K941234 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023719: MP-1 Micro Perimeter, Nidek Technologies Srl (2002) Summary page 3.

## Indications for use
The Optos spectral OCTSLO Micorperimeter is indicated for use for in vivo viewing, axial cross section, and three dimensional imaging and measurement of posterior ocular structures including retina, macula, retinal nerve fibre layer and optic disk- It is used as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior of the eye. In addition, cornea scleraa dn conjunctiva can be imaged with the system by changing the focal position. The micorperimetry functionality is indicated for use as a fixation examiner locating the patient's subjective answer to light stimuli, generating a sensitivity map of the inspected retinal region.

Source page: https://510kreport.com/device/K121043
Methodology: https://510kreport.com/methodology