The following data is part of a premarket notification filed by Lensar, Inc. with the FDA for Lensar Laser System - Fs 3d (lls-fs 3d).
| Device ID | K173346 |
| 510k Number | K173346 |
| Device Name: | LENSAR Laser System - Fs 3D (LLS-fs 3D) |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | Lensar, Inc. 2800 Discovery Drive Suite 100 Orlando, FL 32826 |
| Contact | Keith Peck |
| Correspondent | Keith Peck 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 | 2017-10-25 |
| Decision Date | 2018-03-02 |
| Summary: | summary |