The following data is part of a premarket notification filed by Alcon Lensx, Inc. with the FDA for Lensx Laser System.
| Device ID | K123120 |
| 510k Number | K123120 |
| Device Name: | LENSX LASER SYSTEM |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | ALCON LENSX, INC. 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Contact | Judy Gordon, Dvm |
| Correspondent | Judy Gordon, Dvm ALCON LENSX, INC. 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| 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 | 2012-10-03 |
| Decision Date | 2012-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380659981623 | K123120 | 000 |