Search Results
Found 1 results
510(k) Data Aggregation
K Number
K120235Device Name
MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP
Manufacturer
AEROLASE MEDICAL LASERS LLC
Date Cleared
2012-09-17
(236 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
AEROLASE MEDICAL LASERS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aerolase Nd:YAG Laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery, podiatry, and urology for surgical and aesthetic applications.
Dermatology:
The Aerolase Nd:YAG Laser is intended for the coagulation and hemostasis of benian vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte: and treatment of benian cutaneous lesions, such as warts, scars, striae, debridement of decubitus ulcer, treatment of keloids, and psoriasis. The laser is also intended for the treatment of benian 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 Aerolase Nd:YAG Laser is 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.
The Aerolase Nd:YAG Laser is also indicated for the treatment of wrinkles, such as. but not limited to, periocular and perioral wrinkles.
The Aerolase Nd:YAG Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Aerolase Nd:YAG Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The Aerolase Nd: YAG Laser is also indicated for the removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Aerolase Nd:YAG Laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Podiatry:
Podiatry (ablation, vaporization, incision, excision, and coaqulation of soft tissue), including:
- . Matrixectomy:
- . Periungual and subungual warts:
- Plantar warts: ●
- Radical nail excision; ◆
- Neuromas. .
General Surgery:
The Aerolase Nd: YAG Laser is indicated for the incision/excision and cutting, ablation, coaqulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy gastroenterology, general surgery, head and neck/otolaryngology (ENT) neurosurgery, oculaplastics, orthopedics, plastic surgery, pulmonary/ thoracic surgery, gynecology (e.g. menorrhagia), podiatry and urology. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Device Description
The Aerolase Nd:YAG 1064nm Laser is Neodynmium doped Yttriuim-Aluminum-Garnet ("Nd:YAG") Laser. This device consists of the following components and accessories: a power supply unit with an air-cooling system, and a laser hand piece connected to the power supply/air cooling system using umbilical cords. Laser parameters are controlled from a display panel located on the front of the power supply unit.
Ask a Question
Page 1 of 1