Nidek EpiStar Diode Laser System Receives FDA Clearance

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Nidek EpiStar Diode Laser System Receives FDA Clearance Posted by
Nidek EpiStar Diode Laser System Receives FDA Clearance

FREMONT, Calif., Aug. 21 /PRNewswire/ -- Nidek, Inc. announced today that
the Food and Drug Administration has granted 510(k) clearance for the EpiStar
Diode Laser System for hair removal, and the treatment of vascular and
pigmented skin lesions. Nidek's EpiStar Diode Laser System is a
state-of-the-art portable, multi-functional system.
Nidek's EpiStar Diode Laser System features a unique thermo-electric
cooling system, a proprietary Nidek design that runs electronically. The
system cools the skin to 5 degrees 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 a two to five millimeter (2 to 5 mm) area in a random scanning pattern,
allowing for complete homogeneity and protection of the epidermis. The
EpiStar runs on 110 volts, featuring an easy-to-use touch screen display and
interchangeable hand pieces for varied treatment sizes.
"We are pleased that the 510(k) clearance of the EpiStar allows us to
provide doctors with additional treatment therapies for patients in their
practices," states Hiroshi Okada, Vice President and General Manager of Nidek,
Inc. "The EpiStar is another way that Nidek aids a physician in ensuring the
quality care of patients. Nidek is dedicated to developing cutting-edge
surgical equipment and advancing the field of medicine."
Nidek's family of laser equipment also includes the Nidek UniPulse 1040, a
sealed CO(2) laser system operating on a char-free pulsing waveform for soft
tissue surgical applications in a variety of medical specialties. The Nidek
surgical laser line also includes the Prima KTP, a 532 nanometer
dermatological laser for the treatment of vascular and pigmented lesions.
Both the UniPulse 1040 and Prima KTP include a Computer Pattern Generator for
integrated, high-speed laser treatments.
With U.S. operations headquartered in Fremont, California, Nidek, Inc.
sells and distributes laser systems and diagnostic equipment developed and
manufactured by Nidek Japan, for uses in ophthalmology, optometry, general
surgery, gynecology and cosmetic dermatological surgery. The Company's
ophthalmic and optometric products are specifically designed for diagnosing
and treating retinal diseases, glaucoma, refractive therapies, retinopathy of
prematurity, and pre and post-operative cataract surgery therapy. Its
surgical products are designed to treat patients in the growing applications
of cosmetic laser surgery and laser skin resurfacing. Nidek distributes its
products through a network of distribution partners and a direct sales force.
For additional information, please visit the company's website at

Company Contact:
For more information, please contact Terry Osborn, National Sales and
Product Manager, Surgical Division at Nidek Inc, by phone at (817) 557-2650 or
by fax at (817) 557-2950.

Media Contact:
Dawn Verhulst, (310) 385-8530,

SOURCE Nidek, Inc.

-0- 08/21/2000

/CONTACT: Dawn Verhulst for Nidek, Inc., 310-385-8530,

Web Site: /

CO: Nidek, Inc.

ST: California




-- LAM006 --

1983 08/21/2000 08:03 EDT

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