FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stellaris Elite vision enhancement system
K Number: K232084
·
Decision Feb 26, 2024
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
311
Applicant Total
1
Review Days
228
Basic Information
- Device Name
- Stellaris Elite vision enhancement system
- K Number
- K232084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4670
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bausch and Lomb
- Date Received
- July 13, 2023
- Decision Date
- February 26, 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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