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FDA 510(k) Application Details - K103547
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K103547
Device Name
Laser, Ophthalmic
Applicant
LIGHTMED CORP.
NO.1-1, LANE1,PAO-AN ST. SEC.3
SHULIN CITY 238 TW
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Contact
JOCELYN LIU
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
12/02/2010
Decision Date
11/03/2011
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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