Sciton BBL Hero

K213350 (Sciton, Inc, 2022)

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-Vl), 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.

Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.

K032460 (Sciton, Inc, 2003)

The Profile BBL (and the light and/or laser delivery accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. It is intended for use for: The treatment of tattoos; The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); The treatment of cutaneous lesions including warts, scars and striae; The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; and The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction. The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to: Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling); Reduce discomfort during and/or associated with light or laser treatment; Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation; Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.