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FDA 510(k) Application Details - K223132
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K223132
Device Name
Laser, Ophthalmic
Applicant
Iridex Corporation
1212 Terra Bella Ave.
Mountain View, CA 94043 US
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Contact
Bill Hyatt
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Regulation Number
886.4390
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Classification Product Code
HQF
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More FDA Info for this Product Code
Date Received
10/03/2022
Decision Date
11/09/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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