510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914393Substantially Equivalent

Retina Tester

Retina Tester, Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914393 is the FDA 510(k) clearance record for RETINA TESTER, a class II device, cleared for Retina Tester on under FDA product code HLX (Photostimulator, Ac-Powered). FDA records list one 510(k) clearance for Retina Tester. As of , FDA records show no recalls naming K914393.

Clearance record

Decision date
Received
(153 days to decision)
Product code
HLX Photostimulator, Ac-Powered
Regulation
21 CFR 886.1630
Device class
Class II
Review panel
Ophthalmic
Applicant
Retina Tester 3637 Park Ave., Memphis TN
510(k) summary
Statement
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