Asclepion Laser Technologies GmbH - FDA 510(k) Cleared Devices

Asclepion Laser Technologies GmbH, is a leader in medical laser technology for aesthetic medicine and surgery. The company has operated since 1977 and serves customers in more than 70 countries. Asclepion maintains a manufacturing facility in Chelmsford, US, and specializes in innovative laser systems for dermatological and surgical applications.

The company has received 29 FDA 510(k) clearances from 29 total submissions, with no denied submissions on record. 93% of submissions focus on General & Plastic Surgery devices, reflecting the company's core expertise in this category. Asclepion's regulatory history spans from 2004 to 2026, demonstrating sustained innovation and market presence in medical laser technology.

The company's product portfolio includes advanced laser systems such as the MeDioStar, Dermablate, PicoStar, and MultiPulse platforms. These devices address applications including hair removal, tattoo removal, skin resurfacing, and surgical procedures. Asclepion's technology foundation includes diode, Er:YAG, Pico, CO2, and holmium laser platforms.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.