FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
K Number: K000327
·
Decision May 2, 2000
Classifications
1
FEI Numbers
74
Registration Numbers
75
Same Product Code
34
Applicant Total
2
Review Days
90
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Basic Information
- Device Name
- WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
- K Number
- K000327
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1760
- Medical Specialty
- Ophthalmic
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Visx, Incorporated
- Date Received
- February 2, 2000
- Decision Date
- May 2, 2000
- Product Code
- HKO
- 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 |
|---|---|---|---|
| HKO | Refractometer, Ophthalmic | FDA class 1 | Ophthalmic |
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Other Clearances by Visx, Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K043503 | VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 | Apr 5, 2005 | Substantially Equivalent |