Home / 510(k) Clearances / K203569

510(k) K203569

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants by Fci (France Chirurgie Instrumentation) Sas — Product Code NCB

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)