# K102492: P200MAAF

- Pathway: 510(k) (Special)
- Applicant: Optos Plc.
- Decided: Sep 30, 2010 after 30 days
- Product code: MYC (Ophthalmoscope, Laser, Scanning)
- 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 K871268 (1987). 8 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060424: Panoramic, Model 200MA, Optos Plc. (2006) Summary page 1.
- K100644: Optos Limited Panoramic 200CAF, Optos Plc. (2010) Summary page 3.

## Most influential descendants
- K142897: P200DTx (2015), 5 descendants of its own
- K173707: P200TE (2018), 3 descendants of its own
- K231673: P200TE (A10700) (2023), 1 descendant of its own
- K233602: P200TE (A10700) (2024), 0 descendants of its own
- K221320: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX (2023), 0 descendants of its own

## Indications for use
The P200MAAF scanning laser ophthalmoscope is indicated for use as a wide field and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

Source page: https://510kreport.com/device/K102492
Methodology: https://510kreport.com/methodology
