510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830557Substantially Equivalent

Erg-Jet Electrode

Universo S.A., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830557 is the FDA 510(k) clearance record for ERG-JET ELECTRODE, a class II device, cleared for Universo S.A. on under FDA product code HLZ (Electrode, Corneal). FDA records list one 510(k) clearance for Universo S.A. As of , FDA records show no recalls naming K830557.

Clearance record

Decision date
Received
(36 days to decision)
Product code
HLZ Electrode, Corneal
Regulation
21 CFR 886.1220
Device class
Class II
Review panel
Ophthalmic
Applicant
Universo S.A. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HLZ

Trailing 12 months
1 clearance under product code HLZ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HLZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260