510(k) Report

FDA product code · Obstetrics and gynecology

Laser, Neodymium:Yag For Gynecologic Use

LLWClass II21 CFR 884.4550510(k) required1 decision since 19850 recalls

1 FDA decision since 1985. 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, obstetrics and gynecology panel

Twenty years of LLW 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 · LLW

FDA has decided no LLW device since 2007.

Median 510(k) review, days · LLW

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

Recalls per year · LLW

No recall names LLW since 2007.

Adverse event reports per year · LLW

No MAUDE report names LLW 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 — LLW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LLW? 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 LLW lately?

  • K850437Disposable LaryngoscopeVital Signs, Inc. · 1985

The one LLW decision →

Related product codes

Other codes under 21 CFR 884.4550.

HHR Laser, Surgical, Gynecologic