# K092326: Smoothcool

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical, Inc.
- Decided: Mar 5, 2010 after 213 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The left handpiece (560nm) of the SmoothCool is indicated for the treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (diffuse redness). The right handpiece (700nm) is indicated for hair removal (permanent hair reduction).

Source page: https://510kreport.com/device/K092326
Methodology: https://510kreport.com/methodology