FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
K Number: K043503
·
Decision Apr 5, 2005
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
2
Review Days
106
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Basic Information
- Device Name
- VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
- K Number
- K043503
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Visx, Incorporated
- Date Received
- December 20, 2004
- Decision Date
- April 5, 2005
- Product Code
- HJO
- 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Visx, Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K000327 | WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 | May 2, 2000 | Unknown |