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510(k) K213592

Iridex 810 Laser by Iridex Corporation — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2022
Date Received
November 12, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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