FDA Expands Clearance for Candela Smoothbeam Laser
WAYLAND, Mass.--(BUSINESS WIRE)--Dec. 2, 2004--
Adds Common Skin Condition Seen In Middle-Aged Adults
Candela Corporation (NASDAQ: CLZR) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Smoothbeam(R) diode laser for the treatment of sebaceous hyperplasia, adding to the previously cleared treatments of facial acne, back acne, acne scars and wrinkles.
Sebaceous hyperplasia is a very common skin condition most often seen in middle-aged to older adults. This benign proliferation of the sebaceous gland appears on the skin as small, soft, yellowish papules. Most often, these lesions are located near the nose, cheeks, forehead, and also on the chest.
Suzanne L. Kilmer, M.D., Director of the Laser & Skin Surgery Center of Northern California, stated, "The FDA clearance is great news for Candela. Existing therapies for sebaceous hyperplasia are invasive and the treatment creates social downtime for patients. I have used the Smoothbeam for this application in many patients with great success. Smoothbeam represents an effective solution for sebaceous hyperplasia with little or no downtime for my patients."
Gerard E. Puorro, Candela's President and Chief Executive Officer, said, "The additional clearance for sebaceous hyperplasia represents an important additional indication for Smoothbeam. Adding clinical indications adds incremental value to a laser from a customer's perspective. This FDA clearance is the fifth FDA clearance for Smoothbeam." |
