The following data is part of a premarket notification filed by Lensar, Inc. with the FDA for Tbd.
| Device ID | K112098 |
| 510k Number | K112098 |
| Device Name: | TBD |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | LENSAR, INC. 2800 DISCOVERY DRIVE SUITE 100 Orlando, FL 32826 |
| Contact | Shirley Mcgarvey |
| Correspondent | Shirley Mcgarvey 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 | 2011-07-22 |
| Decision Date | 2011-10-19 |
| Summary: | summary |