# K173285: Joule System

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Jan 29, 2018 after 105 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: 19 generations back to K943450 (1995). 510 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 516 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101916: Joule Multi-Platform System, Sciton, Inc (2011) Summary page 4.
- K081352: Profile Multi-Platform System, Sciton, Inc (2008) Summary page 4.
- K100270: Artisan Aesthetic System, Palomar Medical Technologies, Inc. (2010) Summary page 4.
- K110907: Palomar Icon (TM) Aesthetic System, Palomar Medical Technologies, Inc. (2011) Summary page 4.
- K142376: Palomar Icon Aesthetic System, Cynosure, Inc. (2014) Summary page 4.

## Most influential descendants
- K180508: Joule System (2018), 3 descendants of its own
- K233803: UltraClear Laser System (N/A) (2024), 1 descendant of its own
- K253245: Boston 2910 (Boston 2910) (2026), 0 descendants of its own
- K251699: The Botticelli (Model: Athena) (2025), 0 descendants of its own
- K210847: UltraClear Fractional Laser System (2021), 0 descendants of its own

## Indications for use
The Joule 2940 nm ProFractional System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia.

Source page: https://510kreport.com/device/K173285
Methodology: https://510kreport.com/methodology