510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K021643Substantially Equivalent

Ha Orbital Implant

Laboratoire Villanova, Le Touquet, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021643 is the FDA 510(k) clearance record for HA ORBITAL IMPLANT, a class II device, cleared for Laboratoire Villanova on under FDA product code HPZ (Implant, Eye Sphere). FDA records list one 510(k) clearance for Laboratoire Villanova. As of , FDA records show no recalls naming K021643.

Clearance record

Decision date
Received
(207 days to decision)
Product code
HPZ Implant, Eye Sphere
Regulation
21 CFR 886.3320
Device class
Class II
Review panel
Ophthalmic
Applicant
Laboratoire Villanova Residence Blue Marine, Le Touquet, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HPZ

Trailing 12 months

FDA records hold no clearances under product code HPZ in the trailing twelve months.

FDA records show no clearances under product code HPZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HPZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260