FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
K Number: K062930
·
Decision Nov 8, 2006
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
3
Applicant Total
16
Review Days
41
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Basic Information
- Device Name
- LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
- K Number
- K062930
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 886.1760
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alcon Research, Ltd.
- Date Received
- September 28, 2006
- Decision Date
- November 8, 2006
- Product Code
- NCF
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NCF | Aberrometer, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NCF), ordered by most recent decision date.
OPD-STATION SOFTWARE
FDA 510(k)
FDA Class 1
·Ophthalmic
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
FDA 510(k)
FDA Class 1
·Ophthalmic
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