# K200616: E>EyeC

- Pathway: 510(k) (Traditional)
- Applicant: E-Swin
- Decided: Jun 11, 2020 after 94 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K943450 (1995). 551 ancestors in all.
No later device cites it as a predicate yet.
0 of 552 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170060: M22 and ResurFx Systems, Lumenis, Ltd. (2017) Summary page 5.
- K192539: Deka Luxea, El.En Electronic Engineering Spa (2019) Summary page 5.

## Indications for use
The E>Eye is a prescription device intended for the treatment of rosacea

Source page: https://510kreport.com/device/K200616
Methodology: https://510kreport.com/methodology