FDA product code NCF: Aberrometer, Ophthalmic
NCF is the FDA product code for aberrometer, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1760 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under NCF, from 3 different applicants. The average 510(k) review took 84 days (median 62). FDA has posted 2 recalls for NCF devices.
Classification
| Field | Value |
|---|---|
| Device name | Aberrometer, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1760 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NCF clearance
Top NCF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alcon Laboratories, Inc. | 2 | 2002-10-18 |
| Alcon Research, Ltd. | 1 | 2006-11-08 |
| Nidek, Inc. | 1 | 2005-08-24 |
Most recent NCF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062930 | Alcon Research, Ltd. | LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | 2006-11-08 | 41 |
| K050336 | Nidek, Inc. | OPD-STATION SOFTWARE | 2005-08-24 | 195 |
| K023249 | Alcon Laboratories, Inc. | ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | 2002-10-18 | 18 |
| K000637 | Alcon Laboratories, Inc. | CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) | 2000-05-19 | 84 |
Recalls for NCF devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-06-30.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code NCF?
NCF is the FDA product code for aberrometer, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1760 and reviewed by the Ophthalmic panel.
What device class is NCF?
Class I, regulation 21 CFR 886.1760. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NCF?
Across 4 cleared submissions the average was 84 days from receipt to decision (median 62).
Which companies have the most NCF clearances?
Alcon Laboratories, Inc. (2); Alcon Research, Ltd. (1); Nidek, Inc. (1).
Have NCF devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2017-06-30.
Next steps
- Run an FDA pathway report with predicate devices for product code NCF
- Run a recall and safety report across every NCF manufacturer
- Watch product code NCF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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