510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053298Substantially Equivalent

Alphasphere Orbital Implant

Hydron, Ltd., Laguna Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053298 is the FDA 510(k) clearance record for ALPHASPHERE ORBITAL IMPLANT, a class II device, cleared for Hydron Pty Limited on under FDA product code HPZ (Implant, Eye Sphere). FDA records list 3 510(k) clearances for Hydron Pty Limited, from to . As of , FDA records show no recalls naming K053298.

Clearance record

Decision date
Received
(165 days to decision)
Product code
HPZ Implant, Eye Sphere
Regulation
21 CFR 886.3320
Device class
Class II
Review panel
Ophthalmic
Applicant
Hydron Pty Limited 733 Bolsana Dr., Laguna Beach CA
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