FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
K Number: K203569
·
Decision Jun 11, 2021
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
4
Review Days
186
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Basic Information
- Device Name
- Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
- K Number
- K203569
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5700
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fci (France Chirurgie Instrumentation) Sas
- Date Received
- December 7, 2020
- Decision Date
- June 11, 2021
- Product Code
- NCB
- 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 |
|---|---|---|---|
| NCB | Weights, Eyelid, Implantable | FDA class 2 | Ophthalmic |