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FDA 510(k) Application Details - K190448
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K190448
Device Name
Laser, Ophthalmic
Applicant
Light-Med(USA), INC.
1130 Calle Cordillera
San Clemente, CA 92673 US
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Contact
Hedy Chiang
Other 510(k) Applications for this Contact
Regulation Number
886.4390
More FDA Info for this Regulation Number
Classification Product Code
HQF
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More FDA Info for this Product Code
Date Received
02/25/2019
Decision Date
05/24/2019
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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