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FDA 510(k) Application Details - K021538
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K021538
Device Name
Laser, Ophthalmic
Applicant
LIGHTMED CORP.
NO.1-1, LANE1,PAO-AN ST. SEC.3
SHULIN CITY 238 TW
Other 510(k) Applications for this Company
Contact
IRENE LIN
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
05/10/2002
Decision Date
08/08/2002
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
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