510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972661Substantially Equivalent

Eye Sphere, Conformers

Gulden Ophthalmics, Elkins Park PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972661 is the FDA 510(k) clearance record for EYE SPHERE, CONFORMERS, a class II device, cleared for Gulden Ophthalmics on under FDA product code HPZ (Implant, Eye Sphere). FDA records list one 510(k) clearance for Gulden Ophthalmics. As of , FDA records show 13 recalls naming K972661.

Clearance record

Decision date
Received
(79 days to decision)
Product code
HPZ Implant, Eye Sphere
Regulation
21 CFR 886.3320
Device class
Class II
Review panel
Ophthalmic
Applicant
Gulden Ophthalmics 225 Cadwalader Ave., Elkins Park PA
510(k) summary
Summary
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