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Biotech / Medical : Palomar Medical Technologies, Inc.

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To: David D. Long who wrote (85)	10/30/1996 11:29:00 PM
From: Dr. Dennis J. Wydra	of 708

This was posted in Yahoo a few days ago. BEVERLY, Mass., Oct 22 (Reuter) - Palomar Medical Technologies Inc said Tuesday it has received a letter from the Food and Drug Administration notifying the company not to promote Epilaser for hair removal. Previously, Palomar said it had received clearance from the FDA to sell and market Epilaser for a range of dermatological applications. Although Palomar received this FDA clearance for certain dermatological uses, it said it did not include hair removal. Subsequently, Palomar submitted additional data in its application to the FDA to request clearance to sell and market Epilaser specifically for hair removal. "Our 510(k) application for hair removal is now being reviewed by the FDA, and the company believes that this letter will have no effect on that process," said Steven Georgiev, chairman and chief executive officer of Palomar, in a statement. Palomar said it reviewed its promotional literature and believes that it is in compliance with all FDA regulations. Palomar supplies laser systems for medical, dermatological and cosmetic laser treatments. Shares of Palomar were trading off 1-1/16 to 7-3/4. Chicago newsdesk 312 408 8787

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