510(k) Report

FDA product code · Ophthalmic

System, In-Office Tinting, Contact Lenses

MZDClass II21 CFR 886.5925510(k) required1 decision since 19990 recalls

1 FDA decision since 1999. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ophthalmic panel

Twenty years of MZD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MZD

FDA has decided no MZD device since 2007.

Median 510(k) review, days · MZD

Too few MZD 510(k)s in any year since 2007 to give a median.

Recalls per year · MZD

No recall names MZD since 2007.

Adverse event reports per year · MZD

No MAUDE report names MZD since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MZD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MZD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

What has FDA decided in MZD lately?

  • K991995Softchrome Tints, Transparent Tinted Soft Contact LensSoftchrome, Inc. · 1999

The one MZD decision →

Related product codes

Other codes under 21 CFR 886.5925.

LPM Lenses, Soft Contact, Extended WearNIC Lens, Contact, For Reading DiscomfortMVN Lens, Contact, (Disposable)NCZ Lens, Contact, For Color Vision DeficiencyLPL Lenses, Soft Contact, Daily Wear