Opd-Station Software
FDA 510(k) K050336 · Nidek, Inc.
510(k) numberK050336
Submission
- Device name
- Opd-Station Software
- Applicant
- Nidek, Inc.
Lake Forest, CA, US - Received
- February 10, 2005
- Decision date
- August 24, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NCF – Aberrometer, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1760
- Specialty
- Ophthalmic
Other 510(k)s with product code NCF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K062930 | Ladarwave Customcornea Wavefront SystemNCF · Abbreviated | Alcon Research, Ltd. | 11/08/2006SE |
| K023249 | Alcon Ladarwave Customcornea Wavefront SystemNCF · Abbreviated | Alcon Laboratories, Inc. | 10/18/2002SE |
| K000637 | Customcornea Measurement Device (CCMD)NCF · Traditional | Alcon Laboratories, Inc. | 05/19/2000SESU |
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Questions and answers
When was Opd-Station Software cleared by the FDA?
Opd-Station Software (K050336) received a 510(k) decision of Substantially Equivalent on August 24, 2005, 195 days after the submission was received.
What is the product code of K050336?
The FDA product code is NCF – Aberrometer, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1760.