K-number	K042740
Device name	ISC-1000 PENTAX CONFOCAL LASER SYSTEM
Applicant	Pentax Medical Company
Product code	GCJ
Device class	Class II
Decision date	Oct 19, 2004
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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ISC-1000 PENTAX CONFOCAL LASER SYSTEM

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