# K213761: Joule diVa System

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Jul 19, 2022 after 230 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: 22 generations back to K943450 (1995). 516 ancestors in all.
No later device cites it as a predicate yet.
0 of 517 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.
- K060033: Profile Multi-Platform System, Sciton, Inc (2006) Summary page 4.
- K210634: MCL 31 Dermablate System, Asclepion Laser Technologies GmbH (2022). Cleared while this submission was under review Summary page 4.

## Indications for use
The JOULE diVa Laser Device with its accessories is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes). The JOULE diVa Laser System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

Source page: https://510kreport.com/device/K213761
Methodology: https://510kreport.com/methodology