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FDA 510(k) Application Details - K121475
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K121475
Device Name
Powered Laser Surgical Instrument
Applicant
IRIDEX CORP.
1212 Terra Bella Ave
MOUNTAIN VIEW, CA 94043 US
Other 510(k) Applications for this Company
Contact
PAUL H HARDIMAN
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/18/2012
Decision Date
11/28/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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