510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K093521Substantially Equivalent

Gdxpro

Carl Zeiss Meditec Inc, Dublin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093521 is the FDA 510(k) clearance record for GDXPRO, a class II device, cleared for Carl Zeiss Meditec, Inc. on under FDA product code MYC (Ophthalmoscope, Laser, Scanning). FDA records list 78 510(k) clearances for Carl Zeiss Meditec, Inc., from to . As of , FDA records show no recalls naming K093521.

Clearance record

Decision date
Received
(12 days to decision)
Product code
MYC Ophthalmoscope, Laser, Scanning
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Carl Zeiss Meditec, Inc. 5160 Hacienda Dr., Dublin CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code MYC

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