The Alma Hybrid Laser System

The Alma Hybrid Laser System is a multi-wavelength surgical laser (CO2 at 10600 nm and 1570 nm) designed for ablation, vaporization, excision, incision, and coagulation of soft tissue across multiple medical specialties including dermatology, plastic surgery, podiatry, gynecology, neurosurgery, orthopedics, otolaryngology, general surgery, dental/oral surgery, and genitourinary procedures. It features fractional and non-fractional applicators (Pixel, HyLight, and ProScan) for performing skin resurfacing, scar treatment, lesion removal, and other surgical applications.

The device has identical wavelengths (10600 nm and 1570 nm), pilot beam specifications (650 nm, 3 mW), operation modes (repeat pulse/continuous wave), spot sizes (0.15–3.1 mm for HyLight; 0.125–0.20 mm pixels for Pixel), repetition rates (1–5 Hz), pulse durations (10–1000 ms), and maximum fluence parameters compared to the primary predicate K203441. Output power is 30 W or 70 W in both systems. ProScan applicator specifications match the predicate in scan diameter (up to 30 mm) and output energy (24–144 mJ/pixel).

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-1, ISO 17665-1, IEC 62304, and ISO 14971. Testing was performed under the previous clearance K230441.

The subject device shares identical technological parameters (wavelengths, power outputs, spot sizes, repetition rates, and fluence characteristics) with the primary predicate K203441 and uses the same laser principles. The device has the same intended use (surgical soft tissue ablation/vaporization/coagulation) and the same or expanded indications covering multiple surgical specialties. Risk assessment and supporting documentation demonstrate that changes do not affect safety and effectiveness, and no new testing beyond the previously cleared submission is required. Because the technical design, operation, and indications are substantially identical to the predicate, substantial equivalence is established.