Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K003385
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K003385
Device Name
Powered Laser Surgical Instrument
Applicant
BIOLASE TECHNOLOGY, INC.
981 CALLE AMANECER
SAN CLEMENTE, CA 92673 US
Other 510(k) Applications for this Company
Contact
IOANA M RIZOIU
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
10/31/2000
Decision Date
01/25/2001
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact