Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K120870
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K120870
Device Name
Powered Laser Surgical Instrument
Applicant
AMERICAN MEDICAL SYSTEMS
3070 ORCHARD DRIVE
SAN JOSE, CA 95134 US
Other 510(k) Applications for this Company
Contact
DOREEN NAKAMURA
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
03/22/2012
Decision Date
06/15/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact