FDA 510(k) Application Details - K242397

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K242397
Device Name	Laser, Ophthalmic
Applicant	Norlase Aps Brydehusvej 13 Ballerup 2750 DK Other 510(k) Applications for this Company
Contact	Jan Forstberg Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	HQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2024
Decision Date	10/25/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review