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FDA 510(k) Application Details - K220877
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K220877
Device Name
Laser, Ophthalmic
Applicant
Lumenis Be, Inc.
1870 South Milestone Drive
Salt Lake City, UT 84104 US
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Contact
Shlomit Segman
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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
03/25/2022
Decision Date
07/15/2022
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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