Manufacturer
Alma Lasers, Inc.The Alma Hybrid Laser System
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251230
- Device name
- The Alma Hybrid Laser System
- Company
- Alma Lasers, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-04-21
- Decision date
- 2025-05-21
- 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 Alma Hybrid Laser System (Pixel and HyLight CO2 Applicators) is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee). The Alma Hybrid Laser System is cleared for use for the particular indications 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 dermabrasion • Laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of: • Wrinkles, rhytids, and furrows (including fines 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, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica; • Vermilionectomy 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; • Aden sebaceous 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; • Trichoepitheliomas; • Xanthelasma Palpebrarum; • Syringoma Laser ablation, vaporization and/or excision for complete or partial nail matrixectomy. Vaporization/coagulation of: • Benign/malignant vascular/avascular skin lesions; • Moh's Surgery; • Lipectomy; • Verrucae and seborrheic vulgaris, including paronychial, perifungal, 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 vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts; • Fungal nail treatment; • Porokeratoma ablation; • Ingrown nail treatment; • Neuromas/fibromas, including Morton's neuroma; • Debrideme
Intended Use
The Alma Hybrid Laser System (Pixel and HyLight CO2 Applicators) is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).
Device Description
The Alma Hybrid Laser System consists of: Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel); LCD control panel with touch-screen technology; Two wavelengths – CO2 and 1570 nm; Articulated arm; Footswitch; Delivery devices (Pixel applicators, Hylight applicators, Proscan applicator).
Summary parsed at:2026-06-01 05:23:01 UTC
Predicate devices
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The Alma Hybrid Laser System
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K251230 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251230 as a predicate
