NCF · Aberrometer, Ophthalmic
Ophthalmic · 21 CFR 886.1760 · Class 1
Overview
| Product Code | NCF |
|---|---|
| Device Name | Aberrometer, Ophthalmic |
| Regulation | 21 CFR 886.1760 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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 | LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Alcon Research, Ltd. | Nov 8, 2006 | SESE |
| K050336 | OPD-STATION SOFTWARE | Nidek, Inc. | Aug 24, 2005 | SESE |
| K023249 | ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Alcon Laboratories, Inc. | Oct 18, 2002 | SESE |
| K000637 | 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
