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510(k) K212741

EZYPOR by Fci (France Chirurgie Instrumentation) Sas — Product Code HPZ

K212741 is an FDA 510(k) premarket notification submitted by Fci (France Chirurgie Instrumentation) Sas for the device "EZYPOR". The FDA issued a decision of Substantially Equivalent on June 24, 2022. The device falls under product code HPZ (Implant, Eye Sphere), a Class II device regulated under 21 CFR 886.3320. Fci (France Chirurgie Instrumentation) Sas has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2022
Date Received
August 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Sphere
Device Class
Class II
Regulation Number
886.3320
Review Panel
OP
Submission Type

Other clearances by Fci (France Chirurgie Instrumentation) Sas

  • K203569 — Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants (June 11, 2021)
  • K201892 — Ritleng®+ and Ritleng®+ PVP (March 11, 2021)
  • K201606 — LacriJet® (December 18, 2020)
  • K161373 — Nunchaku (November 3, 2016)

Other clearances for product code HPZ

  • K123764 — DURETTE OCULAR IMPLANT (January 31, 2013)
  • K110554 — BIOCERAMIC ORBITAL IMPLANT, ORBTEX (November 2, 2011)
  • K112176 — SILICONE SPHERES (September 15, 2011)
  • K083342 — ORBITAL RECONSTRUCTIVE IMPLANT II (March 12, 2009)
  • K082850 — EYE SPHERES (February 27, 2009)
  • K073293 — DURETTE IMPLANT (March 19, 2008)
  • K071335 — MEDPOR ATTRACTOR IMPLANT (August 8, 2007)
  • K070130 — ORBITAL RECONSTRUCTIVE IMPLANT (April 19, 2007)
  • K053298 — ALPHASPHERE ORBITAL IMPLANT (May 9, 2006)
  • K040851 — MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM (July 16, 2004)

FDA data resources