The following data is part of a premarket notification filed by Lensx Lasers, Inc. with the FDA for Lensx Laser System.
| Device ID | K101626 |
| 510k Number | K101626 |
| Device Name: | LENSX LASER SYSTEM |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | LENSX LASERS, INC. 733 BOLSANA DR. Laguna Beach, CA 92651 |
| Contact | Judy Gordon |
| Correspondent | Judy Gordon LENSX LASERS, INC. 733 BOLSANA DR. Laguna Beach, CA 92651 |
| Product Code | OOE |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-09 |
| Decision Date | 2010-10-18 |
| Summary: | summary |