NCF
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Aberrometer, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1760
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 2021: 46 · 2022: 38 · 2023: 36 · 2024: 34 · 2025: 39 · 2026: 33
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K062930) | Alcon Research, Ltd. | 2006-11-08 |
| OPD-STATION SOFTWARE (K050336) | Nidek, Inc. | 2005-08-24 |
| ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K023249) | Alcon Laboratories, Inc. | 2002-10-18 |
| CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) (K000637) | Alcon Laboratories, Inc. | 2000-05-19 |
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Every clearance here is in the API, with alerts when new ones post.