The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Lensx Laser System.
| Device ID | K161288 |
| 510k Number | K161288 |
| Device Name: | LenSX Laser System |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | ALCON LABORATORIES, INC. 20511 LAKE FOREST DR Lake Forest, CA 92630 |
| Contact | James Arganda |
| Correspondent | James Arganda ALCON LABORATORIES, INC. 20511 LAKE FOREST DR Lake Forest, CA 92630 |
| Product Code | OOE |
| Subsequent Product Code | HNO |
| Subsequent Product Code | HQC |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-09 |
| Decision Date | 2016-11-16 |
| Summary: | summary |