# K251077: JOULE 1064nm System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Dec 19, 2025 after 255 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). 414 ancestors in all.
No later device cites it as a predicate yet.
0 of 415 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023881: Profile 1064 Laser System, Sciton, Inc (2003) Summary page 6.
- K122567: Joule 810/940/980 Multi-Platform System, Sciton, Inc (2013) Summary page 6.

## Indications for use
The 1064 Laser Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. When used with the specified treatment protocol, it is also intended for histological clearance of biopsy-confirmed nodular or superficial basal cell carcinoma (BCC) located on the trunk, in individuals with Fitzpatrick skin types I-II. The rate of recurrence after this procedure is not known. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The 1064 Laser System and Accessories are indicated for use on all skin types (Fitzpatrick I-Vl), including tanned skin. The 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles. Surgical Applications: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Source page: https://510kreport.com/device/K251077
Methodology: https://510kreport.com/methodology