# K031489: Pitanga

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Aug 19, 2003 after 99 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: 8 generations back to K943450 (1995). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021149: Aurora DS, Syneron Medical, Ltd. (2002)
- K022266: Aurora SR, Syneron Medical, Ltd. (2002) Summary page 1.
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 1.

## Indications for use
The Pitanga is indicated for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superficial benign pigmented lesions.

Source page: https://510kreport.com/device/K031489
Methodology: https://510kreport.com/methodology