510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030393Substantially Equivalent

Optical Low Coherence Reflectometry (Olcr) Pachymeter

Haag-Streit Holding AG, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030393 is the FDA 510(k) clearance record for OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER, a class II device, cleared for Haag-Streit Holding AG on under FDA product code MXK (Device, Analysis, Anterior Segment). FDA records list one 510(k) clearance for Haag-Streit Holding AG. As of , FDA records show no recalls naming K030393.

Clearance record

Decision date
Received
(232 days to decision)
Product code
MXK Device, Analysis, Anterior Segment
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Haag-Streit Holding AG 7361 Calhoun Pl., Suite 500, Rockville MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MXK

Trailing 12 months
2 clearances under product code MXK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MXK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260