Name: Predicase
Price: 199 USD

K-number	K060338
Device name	FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO
Applicant	Lumenis, Inc.
Product code	GEX
Device class	Class II
Decision date	Mar 9, 2006
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO

Everything you need for a 510(k) submission. Nothing you don't.