Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K191962
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K191962
Device Name
Powered Laser Surgical Instrument
Applicant
Quantel Medical
11 Rue du Bois Joli-CS40015
Cournon D'Auvergne-Cedex 63808 FR
Other 510(k) Applications for this Company
Contact
Bruno Pages
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
07/23/2019
Decision Date
12/05/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact