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FDA 510(k) Application Details - K222157
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K222157
Device Name
Laser, Ophthalmic
Applicant
Norlase
Brydehusvej 13
Ballerup DK-2750 DK
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Contact
Jan Forstberg
Other 510(k) Applications for this Contact
Regulation Number
886.4390
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Classification Product Code
HQF
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More FDA Info for this Product Code
Date Received
07/20/2022
Decision Date
10/11/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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