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FDA 510(k) Application Details - K181662
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K181662
Device Name
Powered Laser Surgical Instrument
Applicant
Iridex Corporation
1212 Terra Bella Avenue
Mountain View, CA 94043 US
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Contact
Edward J. Sinclair
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
06/25/2018
Decision Date
09/05/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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