# K080382: Sellas

- Pathway: 510(k) (Traditional)
- Applicant: Dinona Co., Ltd.
- Decided: Sep 24, 2008 after 224 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K141046: Midi-SRS (2014), 0 descendants of its own

## Indications for use
The SellaSGP is intended for use in : Dermatological procedures requiring the coagulation of soft tissue;

Source page: https://510kreport.com/device/K080382
Methodology: https://510kreport.com/methodology