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510(k) K231011

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse by Meridian AG — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2023
Date Received
April 10, 2023
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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  • K023045 — MICRORUPTER V (September 26, 2002)

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