Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1760](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1760) → NCF — Aberrometer, Ophthalmic

# NCF · Aberrometer, Ophthalmic

_Ophthalmic · 21 CFR 886.1760 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NCF

## Overview

- **Product Code:** NCF
- **Device Name:** Aberrometer, Ophthalmic
- **Regulation:** [21 CFR 886.1760](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1760)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K062930](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NCF/K062930.md) | LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Alcon Research, Ltd. | Nov 8, 2006 | SESE |
| [K050336](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NCF/K050336.md) | OPD-STATION SOFTWARE | Nidek, Inc. | Aug 24, 2005 | SESE |
| [K023249](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NCF/K023249.md) | ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Alcon Laboratories, Inc. | Oct 18, 2002 | SESE |
| [K000637](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NCF/K000637.md) | CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) | Alcon Laboratories, Inc. | May 19, 2000 | SESU |

## Top Applicants

- Alcon Laboratories, Inc. — 2 clearances
- Alcon Research, Ltd. — 1 clearance
- Nidek, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NCF](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NCF)

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