# K182173: Joule System

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Mar 6, 2019 after 208 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: 14 generations back to K910422 (1992). 133 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130193: Fraxel Dual 1550/1927 Laser System, Solta Medical, Inc. (2013) Summary page 4.
- K171009: LASEMD Laser System, Lutronic Corporation (2017) Summary page 4.

## Most influential descendants
- K223727: Lavieen (2023), 4 descendants of its own
- K241406: Lavieen (2024), 2 descendants of its own
- K252732: 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) (2025), 1 descendant of its own
- K261589: 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) (2026), 0 descendants of its own
- K251919: Thulium Laser System (Deluxlase) (2025), 0 descendants of its own

## Indications for use
JOULE 1927nm Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

Source page: https://510kreport.com/device/K182173
Methodology: https://510kreport.com/methodology