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 |