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FDA 510(k) Application Details - K120235
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K120235
Device Name
Powered Laser Surgical Instrument
Applicant
AEROLASE MEDICAL LASERS LLC
555 THIRTEENTH STREET
WASHINGTON, DC 20004 US
Other 510(k) Applications for this Company
Contact
JENNIFER A HENDERSON
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
01/25/2012
Decision Date
09/17/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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