# K213705: DRSplus

- Pathway: 510(k) (Special)
- Applicant: Centervue S.P.A.
- Decided: Dec 21, 2021 after 27 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: 9 generations back to K941234 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192113: DRSplus, Centervue S.P.A. (2019) Summary page 5.

## Indications for use
The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color and infrared imaging of a human retina without the use of a mydriatic agent.

Source page: https://510kreport.com/device/K213705
Methodology: https://510kreport.com/methodology