The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories

Lumenis Be, Ltd.

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

Product code GEX· 21 CFR 878.4810

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Company

Israel (IL)

Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K220467
Device name
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
Country / region
Israel(IL)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-02-17
Decision date
2022-05-18
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The UltraPulse SurgiTouch and UltraPulse Encore CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, incision, or coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), 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

Intended Use

The UltraPulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are 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.

Device Description

The Lumenis Be Family of UltraPulse CO2 Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories consist of the following devices: Laser Systems - UltraPulse Alpha, UltraPulse Encore, UltraPulse SurgiTouch; Delivery Devices and Accessories - DeepFX Microscanner and disposable tips, UltraScan CPG Microscanner, TrueSpot 2.0 mm Collimated Handpiece, 0.2 mm and 1.0 mm Focused Incisional Handpieces. Each UltraPulse laser system is an advanced computer-controlled device with RF-modulated CO2 laser tube technology that emits laser beams at a wavelength of 10,600 or 11,100 nm. Each has an additional diode laser in the red visible spectrum emitting along the same optical path as the CO2 to serve as an aiming beam. Attached to each laser system are the delivery devices and accessories that direct the laser beams to the intended treatment site in the format as selected by the user.

Summary parsed at:2026-06-01 05:39:51 UTC

Predicate devices

3

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