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510(k) K242397

LYNX Photocoagulator by Norlase Aps — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2024
Date Received
August 13, 2024
Clearance Type
Traditional
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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