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510(k) K223132

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) by Iridex Corporation — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2022
Date Received
October 3, 2022
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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