Device Classification Name |
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
More FDA Info for this Device |
510(K) Number |
K163632 |
Device Name |
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
Applicant |
Katalyst Surgical, LLC
754 Goddard Avenue
Chesterfield, MO 63005 US
Other 510(k) Applications for this Company
|
Contact |
Meryl Koch
Other 510(k) Applications for this Contact |
Regulation Number |
886.4390
More FDA Info for this Regulation Number |
Classification Product Code |
LQJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
12/22/2016 |
Decision Date |
06/15/2017 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OP - Ophthalmic |
Review Advisory Committee |
OP - Ophthalmic |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|