The Alma Hybrid Laser System

Alma Lasers, Inc.

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K251230
Device name
The Alma Hybrid Laser System
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

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