510(k) K050336
- Device
- OPD-STATION SOFTWARE
- Applicant
- Nidek, Inc.
- 510(k) number
- K050336
- Product code
- NCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-08-24
- Date received
- 2005-02-10
- Regulation
- 886.1760
- Classification name
- Aberrometer, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- CAROL PATTERSON
- Address
- 21911 Erie Ln. Lake Forest CA US 92630 92630
FDA Registration Numbers#
- 3019255798
- 2028159
- 1920664
- 3007606649
- 1651254
- 3010208880
- 3011422483
- 3003288808
- 1313525
- 9710340
- 3011977270
Source Documents#
Other 510(k) Records For Product Code NCF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K062930 | LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Alcon Research, Ltd. | 2006-11-08 |
| K023249 | ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Alcon Laboratories, Inc. | 2002-10-18 |
| K000637 | CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) | Alcon Laboratories, Inc. | 2000-05-19 |