# K080731: Pharaon 980 Endo/Exo, Osyfibre 600, CONTROL4+ Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Osyris
- Decided: Jul 17, 2008 after 125 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
Longest line of descent: 1 generation back to K993911 (2000). 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)
- K993911: Ceralas D Diode Laser System, Model D15, D25,D50, Ceram Optec, Inc. (2000) Summary page 1.
- K024088: Ceralas D 980 Laser System with Endo Laser Vein System Kit, Model: D15 and D25, Biolitec, Inc. (2003) Summary page 1.

## Indications for use
PHARAON 980 ENDO is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. PHARAON 980 EXO is indicated for photocoagulation of teleangectasia of the legs.

Source page: https://510kreport.com/device/K080731
Methodology: https://510kreport.com/methodology