The following data is part of a premarket notification filed by Lensar, Inc. with the FDA for Lensar Laser System - Fs 3d.
Device ID | K143010 |
510k Number | K143010 |
Device Name: | LENSAR Laser System - Fs 3D |
Classification | Ophthalmic Femtosecond Laser |
Applicant | LENSAR, INC. 2800 DISCOVERY DRIVE SUITE 100 Orlando, FL 32826 |
Contact | Mohinder Merchea |
Correspondent | Mohinder Merchea LENSAR, INC. 2800 DISCOVERY DRIVE SUITE 100 Orlando, FL 32826 |
Product Code | OOE |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-20 |
Decision Date | 2015-03-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10867744000119 | K143010 | 000 |
10867744000102 | K143010 | 000 |