Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K123999
Device Classification Name
Over-The-Counter Powered Light Based Laser For Acne
More FDA Info for this Device
510(K) Number
K123999
Device Name
Over-The-Counter Powered Light Based Laser For Acne
Applicant
LA LUMIERE, LLC
611 W. 5TH ST.
AUSTIN, TX 78701 US
Other 510(k) Applications for this Company
Contact
ROBERT SEIPLE, RAC
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
OLP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2012
Decision Date
08/28/2013
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