# K213350: mJOULE System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Apr 15, 2022 after 189 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: 26 generations back to K943450 (1995). 569 ancestors in all.
No later device cites it as a predicate yet.
0 of 570 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191842: Discovery Pico, Discovery Pico Plus, Discovery Pico Derm, Quanta System Spa (2019) Summary page 5.
- K182088: XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro, Fotona D.O.O. (2018) Summary page 5.
- K023881: Profile 1064 Laser System, Sciton, Inc (2003) Summary page 5.

## Indications for use
The mJoule 1064 laser systems and accessories is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastic, 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, venous 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. 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. 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 pseudo folliculitis barbae (PFB). The mJoule 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-V1), including tanned skin. The mJoule 1064 laser system and accessories is indicated for the treatment of facial wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). Treatment of Aphthous Ulcers. Excision and Vaporization of Herpes Simplex I and II. Laser assisted uvulopalatoplasty (LAUP). Laser assisted lipolysis. Treatment of mild to moderate inflammatory acne vulgaris. 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, oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia) and urology.

Source page: https://510kreport.com/device/K213350
Methodology: https://510kreport.com/methodology