510(k) K232417

MR Q; MR Q SUPINE; MR Q SLT by Meridian AG — Product Code HQF

K232417 is an FDA 510(k) premarket notification submitted by Meridian AG for the device "MR Q; MR Q SUPINE; MR Q SLT". The FDA issued a decision of Substantially Equivalent on January 25, 2024. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Meridian AG has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2024
Date Received
August 11, 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