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FDA 510(k) Application Details - K151232
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K151232
Device Name
Powered Laser Surgical Instrument
Applicant
ILOODA CO., LTD
#801-805, Venture Valley 40, Omokcheon-ro 152 beon-gil
Gwonseon-gu, Suwon-si KR
Other 510(k) Applications for this Company
Contact
Suhee Nam
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/08/2015
Decision Date
08/06/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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