The following data is part of a premarket notification filed by Alcon Lensx, Inc. with the FDA for Lenssx Laser System.
| Device ID | K120732 |
| 510k Number | K120732 |
| Device Name: | LENSSX LASER SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | ALCON LENSX, INC. 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Contact | Judy Gordon |
| Correspondent | Judy Gordon ALCON LENSX, INC. 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Product Code | HQC |
| Subsequent Product Code | HNO |
| Subsequent Product Code | OOE |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-09 |
| Decision Date | 2012-09-06 |
| Summary: | summary |