# K082004: Smoothkit+

- Pathway: 510(k) (Special)
- Applicant: Osyris
- Decided: Sep 26, 2008 after 74 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: 2 generations back to K062321 (2006). 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)
- K073617: Pharaon Lipo, Osyris (2008) Summary page 1.

## Indications for use
SMOOTHKIT+ is intended for laser assisted lipolysis.

Source page: https://510kreport.com/device/K082004
Methodology: https://510kreport.com/methodology