# K180508: Joule System

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: May 18, 2018 after 81 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: 20 generations back to K943450 (1995). 515 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 519 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173285: Joule System, Sciton, Inc (2018) Summary page 4.
- K111303: Dermatological Treatment Device Family, Sharplight Technologies, Ltd. (2011) Summary page 4.

## Most influential descendants
- 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 soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).

Source page: https://510kreport.com/device/K180508
Methodology: https://510kreport.com/methodology