# K223685: SmoothCool HR System

- Pathway: 510(k) (Special)
- Applicant: Jeisys Medical, Inc.
- Decided: Jan 4, 2023 after 26 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 K082911 (2008). 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)
- K213484: SmoothCool HR System, Jeisys Medical, Inc. (2022) Summary page 4.

## Indications for use
The SmoothCool HR System is indicated for hair removal (permanent hair reduction).

Source page: https://510kreport.com/device/K223685
Methodology: https://510kreport.com/methodology