Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for the vaporization, incision, excision, ablation or photocoagulation of soft tissue in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry. The intended use of the Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is for the performance of specific surgical applications in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry as follows: Dermatology The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for use in dermatology and plastic surgery for the following applications: • Ablation, vaporization, excision, incision and coagulation of soft tissue in the performance of: - Laser skin resurfacing - Laser dermabrasion - Laser burn debridement • Laser skin resurfacing (ablation and/or vaporization) for the treatment of: - Wrinkles, rhytids and furrows (including fine lines and texture irregularities). • Laser skin resurfacing (ablation, and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: - Keratosis, including actinic and seborrheic keratosis, seborrhoea vulgares, seborrheic wart and verruca seborrheica. - Vermillionectomy of the lip - Cutaneous horns - Solar/actinic elastosis - Cheilitis, including actinic cheilitis - Lentigines, including lentigo maligna or Hutchinson's malignant freckle - Uneven pigmentation/dyschromia - Acne scars - Surgical scars - Keloids including acne keloidalis nuchae - Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telangiectaticum) - Tattoos - Telangiectasia - Removal of small skin tumors, including periungual (Koenen) and subungual fibromas - Superficial pigmented lesions - Adenosebaceous hypertrophy or sebaceous hyperplasia - Rhinophyma reduction - Cutaneous papilloma (skin tags) - Milia - Debridement of eczematous or infected skin - Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions - Nevi, including spider, epidermal and protruding - Neurofibromas • Laser de-epithelialization • Tricoepitheliomas • Xanthelasma palpebrarum • Syringoma • Laser ablation, vaporization, and/or excision for complete and partial nail matrixectomy • Vaporization or coagulation of: - Benign/malignant vascular/avascular skin lesions - Moh's surgery - Lipectomy - Verrucae and seborrhoecae vulgares, including paronychial, periungal and subun
The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for the vaporization, incision, excision, ablation or photocoagulation of soft tissue in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.
The Lumenis AcuPulse Family of CO2 Laser Systems are advanced computer-controlled Carbon Dioxide (CO2) laser systems based on a DC-excited sealed-off CO2 laser tube, that depending on their configuration, can provide up to 30 or 40 Watts on tissue. The AcuPulse Family of CO2 Lasers includes the following system models: The AcuPulse (previously called AcuPulse 30/40ST) system that incorporates a Free Beam Port only. The AcuPulse 40WG System that incorporates a Fiber Port only. The AcuPulse DUO, a new member of the family, which incorporates both a Free Beam Port and a Fiber Port. The AcuPulse DUO laser added to the AcuPulse family represents a combination of the previously cleared AcuPulse 30/40ST and AcuPulse 40WG lasers. The minor differences in technological characteristics between the AcuPulse DUO and the predicate systems exist to facilitate this integration (mechanical and software adaptations that enable having two ports in one System) and do not affect any of the device's functionalities or performance specifications. The AcuPulse DUO System, with the incorporation of both the Free Beam and the Fiber port in one console, shares the same underlying technology and fundamental functionality as the previously cleared AcuPulse Family of CO2 Laser Systems. All of these laser systems are comprised of the following main functional components: a Laser Console with a port: a Free Beam Port to which an articulated arm is attached (AcuPulse model), a Fiber Port to which a Fiber is attached (AcuPulse 40WG), or both the Free Beam Port and Fiber Port (AcuPulse DUO), a Footswitch, Various Free Beam Delivery Device and accessories (AcuPulse and AcuPulse DUO compatible) or Fiber Delivery Devices and accessories (AcuPulse 40WG and AcuPulse DUO compatible). The AcuPulse DUO, similarly to the previously cleared AcuPulse and AcuPulse 40WG, is operated and controlled via proprietary software embedded in the Main controller, Peripheral controller units and PC. The Delivery Devices and accessories, in accordance with their type and compatibility (e.g., Fiber Port or Free Beam port) are shared by all AcuPulse Laser Systems. The Free Beam Delivery Devices and accessories include: Endoscopes/Laparoscopy accessories, Handpieces/Tips, Micromanipulators, and Scanners with accessories and adaptors. The Fibers that may be used with the Fiber Port are supplied with various handpieces (through which the Fiber may be inserted for more convenient handling during surgical procedures) an
Summary parsed at:2026-06-01 05:57:20 UTC
