FDA product code · General and plastic surgery

System, Non-Coherent Light, Photodynamic Therapy

Name: FDA decisions, review times, recalls and adverse event reports for product code MYH
Creator: 510(k) Report

MYHClass IIIPMA required1 decision since 20040 recalls

1 FDA decision since 2004. 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, general and plastic surgery panel

Twenty years of MYH 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 · MYH

FDA has decided no MYH device since 2007.

Median 510(k) review, days · MYH

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

Recalls per year · MYH

No recall names MYH since 2007.

Adverse event reports per year · MYH

1in 2008

2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code MYH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	1
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — MYH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MYH? 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

System, Non-Coherent Light, Photodynamic Therapy

What has FDA decided in MYH lately?