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Biotech / Medical : Palomar Medical Technologies, Inc.
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To: Ted Molczan who wrote (610)12/17/1997 5:14:00 PM
From: Ted Molczan  Read Replies (1) 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
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