K000637 is an FDA 510(k) clearance for the CUSTOMCORNEA MEASUREMENT DEVICE (CCMD). 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 May 19, 2000, 84 days after receiving the submission on February 25, 2000.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1760.
| 510(k) Number | K000637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | February 25, 2000 |
| Decision Date | May 19, 2000 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | NCF — Aberrometer, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1760 |