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 | K171337 |
| 510k Number | K171337 |
| 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 | 2017-05-08 |
| Decision Date | 2017-08-10 |
| Summary: | summary |