Manufacturer
Lumenis, Inc.UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
Country / Region:Israel (IL)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K203544
- Device name
- UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
- Company
- Lumenis, Inc.
- Country / Region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-12-04
- Decision date
- 2020-12-24
- 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 UltraPulse system (UltraPulse and UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and 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. The UltraPulse system is indicated for use in the performance of specific surgical applications in 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 fo
Intended Use
The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and 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.
Device Description
The modified UltraPulse System, member of the UltraPulse SurgiTouch Family of CO2 Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories, is a carbon dioxide laser system based on a Radio Frequency (RF) modulated CO2 laser tube. The modified UltraPulse is based on the following hardware components in the Lumenis Family of UltraPulse CO2 Laser System, Delivery Devices and Accessories: A Laser Console with a Free Beam Port to which an articulated arm is attached, a footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location, and a variety of Free Beam Delivery Device and accessories.
Summary parsed at:2026-06-01 05:48:46 UTC
Predicate devices
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The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
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K203544 references 7 predicate/reference devices
Cited as predicate
1The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
1 submission cite K203544 as a predicate
