The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Lensx Laser System.
| Device ID | K163551 |
| 510k Number | K163551 |
| 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 | 2016-12-19 |
| Decision Date | 2017-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380659982767 | K163551 | 000 |
| 00380659982750 | K163551 | 000 |
| 00380659982743 | K163551 | 000 |