Ladarwave Customcornea Wavefront System
FDA 510(k) K062930 · Alcon Research, Ltd.
510(k) numberK062930
Submission
- Device name
- Ladarwave Customcornea Wavefront System
- Applicant
- Alcon Research, Ltd.
Orlando, FL, US - Received
- September 28, 2006
- Decision date
- November 8, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|---|
| K050336 | Opd-Station SoftwareNCF · Traditional | Nidek, Inc. | 08/24/2005SE |
| 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 Ladarwave Customcornea Wavefront System cleared by the FDA?
Ladarwave Customcornea Wavefront System (K062930) received a 510(k) decision of Substantially Equivalent on November 8, 2006, 41 days after the submission was received.
What is the product code of K062930?
The FDA product code is NCF – Aberrometer, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1760.