510(k) Report

FDA product code · General and plastic surgery

System, Laser, Photodynamic Therapy

MVFClass IIIPMA required8 decisions since 19950 recalls

8 FDA decisions since 1995. 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 MVF 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 · MVF

2in 2025

2008: 22009: 12010: 12011: 12013: 12016: 12018: 12022: 12023: 12025: 2
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MVF

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

Recalls per year · MVF

No recall names MVF since 2007.

Adverse event reports per year · MVF

5in 2025

2007: 12012: 12013: 22014: 32015: 22017: 42018: 142019: 42020: 42021: 42022: 22023: 42024: 52025: 5
2007high 14 (2018) · low 0 (2008)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20082—00
20091—00
20101—00
20111—00
20120—01
20131—02
20140—03
20150—02
20161—00
20170—04
20181—014
20190—04
20200—04
20210—04
20221—02
20231—04
20240—05
20252—05
20260—0—
FIG. 1 — MVF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MVF? 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