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Biotech / Medical : Palomar Medical Technologies, Inc. -- Ignore unavailable to you. Want to Upgrade?

To: Ted Molczan who wrote (610)	12/17/1997 5:14:00 PM
From: Ted Molczan	Read Replies (1) \| Respond to of 708

On 3 Dec 97, Palomar's Star Medical Technologies subsidiary received an FDA 510(k) clearance to market its StarLite diode laser. The bare-bones information is available on FDA's web site: 510(k) Number: K973324 Applicant: STAR MEDICAL TECHNOLOGIES, INCORPORATED Contact: MARCY MOORE 9516 CANDOR OAKS DRIVE RALEIGH, NC 27615 Device: STARLIGHT PULSED DIODE ARRAY LASER SYSTEM Date Received: 09/04/97 Decision Date: 12/03/97 Decision: Substantially Equivalent Panel Code device reviewed by:General & Plastic Surgery Panel Code device classified by:General & Plastic Surgery Product Code: GEX Summary or Statement: SUMMARY Summary only An FDA staffer has confirmed that the device has been cleared for the intended uses, "to remove hair, and dermatology and plastic surgery procedures." It seems a bit surprising that Palomar has not announced this two week old clearance. I strongly doubt that diode laser hair removal efficacy will be any better than that of the present devices, since all that appears to be changing is the method of generating the laser pulses. As long as wavelength, fluence and pulse width fall within the range of the present devices, then the same poor efficacy will be realized. Palomar and MGH have tended to promote the importance of high fluence in the pursuit of efficacy, so it will be interesting to learn whether or not StarLite maintains or extends Epilaser's industry leading peak fluence of 75 J/cm^2. Diode's principal advantages appear to be potentially lower cost and a smaller physical size. It will be interesting to see how they are received in a market that has already been glutted with perhaps 1,000 of the various previously FDA-cleared devices. Ted Molczan molczan@fox.nstn.ca