ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories

Lumenis Be, Ltd.

Country / region:Israel (IL)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

Israel (IL)

Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K233301
Device name
ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories
Country / region
Israel(IL)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-09-29
Decision date
2023-12-01
Submission type
Special
Technology type
CO2(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) is indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, incision, or coagulation of soft tissue in medical specialties including: dermatology and plastic surgery (aesthetic), podiatry, gynecology, general and thoracic surgery, dental and oral surgery and genitourinary surgery as follows:

Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
• Laser skin resurfacing
• Laser derm-abrasion
• Laser burn debridement
• Laser skin resurfacing (ablation and/or vaporization) for 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:
• Keratoses, including actinic and seborrheic keratosis, seborrhoecae 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 and malignant vascular/avascular skin lesions
• Moh's Surgery
• Lipectomy
• Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts
• Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
• Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation

Podiatry
Laser ablation, vaporization, and/or excision of soft tissue for the reduction, removal, and/or treatment of:
• Verrucae vulgares/plantar (warts), including paronychial, periungal and subungual warts
• Porokeratoma ablation
• Ingrown nail treatment
• Neuromas/fibromas, including Morton's neuroma
• Debridement of ulcers
• Other soft tissue le

Intended Use

The Modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) is indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, incision, or coagulation of soft tissue in medical specialties including: dermatology and plastic surgery (aesthetic), podiatry, gynecology, general and thoracic surgery, dental and oral surgery and genitourinary surgery.

Summary parsed at:2026-06-01 05:33:37 UTC

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