# K082911: Smoothcool HR System

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical, Inc.
- Decided: Dec 19, 2008 after 80 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K213484: SmoothCool HR System (2022), 1 descendant of its own
- K223685: SmoothCool HR System (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K082911
Methodology: https://510kreport.com/methodology