510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003442Substantially Equivalent

Modification to Edi Veris System

Electro-Diagnostic Imaging, Inc., Los Altos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003442 is the FDA 510(k) clearance record for MODIFICATION TO EDI VERIS SYSTEM, a class II device, cleared for Electro-Diagnostic Imaging, Inc. on under FDA product code HLX (Photostimulator, Ac-Powered). FDA records list 2 510(k) clearances for Electro-Diagnostic Imaging, Inc., from to . As of , FDA records show no recalls naming K003442.

Clearance record

Decision date
Received
(179 days to decision)
Product code
HLX Photostimulator, Ac-Powered
Regulation
21 CFR 886.1630
Device class
Class II
Review panel
Ophthalmic
Applicant
Electro-Diagnostic Imaging, Inc. 2081 Longden Cir., Los Altos CA
510(k) summary
Summary
Third party review
No

Clearances, product code HLX

Trailing 12 months

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

FDA records show no clearances under product code HLX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HLX, 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