FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Centurion Vision System (Active Sentry) (8065753057)
K Number: K233902
·
Decision Jan 10, 2024
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
311
Applicant Total
26
Review Days
30
Basic Information
- Device Name
- Centurion Vision System (Active Sentry) (8065753057)
- K Number
- K233902
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.4670
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alcon Laboratories, Inc.
- Date Received
- December 11, 2023
- Decision Date
- January 10, 2024
- Product Code
- HQC
- 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | FDA class 2 | Ophthalmic |
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