# K220974: R:GEN

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Vision, Inc.
- Decided: Dec 27, 2022 after 267 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K122202 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153769: R:GEN Laser System, Lutronic Corporation (2016) Summary page 4.

## Indications for use
The R:GEN is indicated for use by an ophthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment, in the treatment of Clinically Significant Macular Edema (CSME).

Source page: https://510kreport.com/device/K220974
Methodology: https://510kreport.com/methodology