# K111483: Joule Clearsense Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Dec 7, 2011 after 190 days
- Product code: PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis)
- 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: 9 generations back to K936109 (1994). 112 ancestors in all.
No later device cites it as a predicate yet.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103626: Cutera Genesisplus Laser System, Cutera, Inc. (2011) Summary page 1.
- K093547: Pinpointe Footlaser, Pinpointe USA, Inc. (2010) Summary page 1.
- K093545: Pinpointe Footlaser Model 6W, 30W, 100W, Incisive, Inc. (Formerly Named Incisive, LLC) (2010) Summary page 1.

## Indications for use
The JOULE ClearSense Laser System is indicated for ablation, vaporization, incision, excision and coagulation of soft tissue, including: Matrixectomy Periungual and subengual warts Planter warts Radical nail excision Neuromas It is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T, menlagrophytes, and/or yeasts Candida albicans, etc.).

Source page: https://510kreport.com/device/K111483
Methodology: https://510kreport.com/methodology