K023249 is an FDA 510(k) clearance for the ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM. This device is classified as a Aberrometer, Ophthalmic (Class I - General Controls, product code NCF).
Submitted by Alcon Laboratories, Inc. (Orlando, US). The FDA issued a Cleared decision on October 18, 2002, 18 days after receiving the submission on September 30, 2002.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1760.
| 510(k) Number | K023249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2002 |
| Decision Date | October 18, 2002 |
| Days to Decision | 18 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NCF — Aberrometer, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1760 |