FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZeptoLink IOL Positioning System
K Number: K223763
·
Decision Apr 11, 2023
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
3
Review Days
117
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Basic Information
- Device Name
- ZeptoLink IOL Positioning System
- K Number
- K223763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4100
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Centricity Vision, Inc.
- Date Received
- December 15, 2022
- Decision Date
- April 11, 2023
- Product Code
- PUL
- 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 |
|---|---|---|---|
| PUL | Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered | FDA class 2 | Ophthalmic |
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