# K153769: R:GEN Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Oct 5, 2016 after 280 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: 1 generation back to K122202 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122202: Ellex 2RT, Ellex Medical Pty, Ltd. (2013) Summary page 5.

## Most influential descendants
- K220974: R:GEN (2022), 0 descendants of its own

## Indications for use
The R:GEN Laser System is indicated for use by an opthalmic 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/K153769
Methodology: https://510kreport.com/methodology