Aberrometer, Ophthalmic
The Ophthalmic Aberrometer is a diagnostic instrument used to measure optical aberrations of the eye, including higher-order aberrations beyond simple sphere and cylinder, using wavefront sensing technology. These measurements guide customized laser vision correction procedures and are used in contact lens fitting and IOL power calculations. Classified as FDA Class 1, it is subject to general controls under regulation 886.1760 (Ophthalmic specialty).
Research product code NCF in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NCF
- Device Class
- FDA class 1
- Regulation Number
- 886.1760
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K062930 | LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Nov 08, 2006 | Substantially Equivalent | Alcon Research, Ltd. |
| K050336 | OPD-STATION SOFTWARE | Aug 24, 2005 | Substantially Equivalent | Nidek, Inc. |
| K023249 | ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Oct 18, 2002 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K000637 | CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) | May 19, 2000 | Unknown | Alcon Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.