Search Results
Found 1 results
510(k) Data Aggregation
(49 days)
The ADEPT ULTRALITE 532 LASER is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue. Examples include: Telangiectasia Spider Naevi Angioma Hemangioma Leg veins (small, superficial) Epidermal Naevi Lentigines (solar and senile) Verrucae Vulgares (Warts) Cherry Angioma Port Wine Stain
The Adept UltraLite 532 Laser is a diode laser which emits coherent light at 532 nm. The Ultralight 532 is a diode pumped solid state frequency doubled laser appliance.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it describes a 510(k) summary for the Adept UltraLite 532 Laser, focusing on its substantial equivalence to predicate devices rather than performance data or analytical/clinical study results.
Specifically, the document states: "Performance Data: None required. The claim of substantial equivalence is based on comparisons of specifications/characteristics and intended uses of the UltraLite 532 and the claimed predicates, i.e., the BeautyStar 532 and DioLite 532 lasers."
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Ask a specific question about this device
Page 1 of 1