FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
K Number: K032978
·
Decision Oct 20, 2003
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
82
Applicant Total
44
Review Days
26
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Basic Information
- Device Name
- MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
- K Number
- K032978
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ciba Vision Corporation
- Date Received
- September 24, 2003
- Decision Date
- October 20, 2003
- Product Code
- HNO
- 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 |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | FDA class 1 | Ophthalmic |
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|---|---|---|---|
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| K062262 | CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS | Nov 14, 2006 | Substantially Equivalent |
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| K050250 | AQUIFY MULTIPURPOSE SOLUTION | Aug 10, 2005 | Substantially Equivalent |
| K050065 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES | May 27, 2005 | Substantially Equivalent |