-Fremont, USA, February 19, 2002-
NIDEK, Inc. announced today that the Food and Drug Administration has granted supplemental 510(k) clearance for the EpiStar Diode Laser System. The EpiStar is now approved for the high fluence treatment of vascular and pigmented skin lesions and hair removal, and an improved, more aggressive cooling device to keep skin comfortable. The newly approved high fluence capability allows for increased effectiveness in treating targeted areas.
The EpiStar features a redesigned integrated cooling device that cools the skin to 5° C, protecting the area from thermal exposure and minimizing patient discomfort, ensuring increased patient satisfaction. The EpiStar utilizes an 810-nanometer infrared diode laser to treat the area in a random scanning pattern, allowing for complete homogeneity and protection of the epidermis.
"The additional approvals for the EpiStar allows doctors to treat patients more quickly and with increased comfort in their practices," states Hiroshi Okada, vice president and general manager, NIDEK, Inc. "Adding these capabilities to NIDEK's existing suite of dermatology treatments is yet another way we support physicians in providing advanced medical tools."
