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510(k) K230228

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) by Iridex Corporation — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2023
Date Received
January 27, 2023
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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