510(k) K203569
K203569 is an FDA 510(k) premarket notification submitted by Fci (France Chirurgie Instrumentation) Sas for the device "Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants". The FDA issued a decision of Substantially Equivalent on June 11, 2021. The device falls under product code NCB (Weights, Eyelid, Implantable), a Class II device regulated under 21 CFR 886.5700. Fci (France Chirurgie Instrumentation) Sas has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2021
- Date Received
- December 7, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Weights, Eyelid, Implantable
- Device Class
- Class II
- Regulation Number
- 886.5700
- Review Panel
- OP
- Submission Type
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)