510(k) Report

FDA product code · General and plastic surgery

Energy Based Device For Treatment Of Tattoos

QHFClass II21 CFR 878.4810510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

To reduce formation of bubbles during laser treatment of tattoos

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 QHF 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 · QHF

FDA has decided no QHF device since 2007.

Median 510(k) review, days · QHF

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

Recalls per year · QHF

No recall names QHF since 2007.

Adverse event reports per year · QHF

2in 2024

2024: 2
2007high 2 (2024) · low 0 (2007)2025

MAUDE reports naming product code QHF, 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—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—02
20250—00
20260—0—
FIG. 1 — QHF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QHF? 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

Related product codes

Other codes under 21 CFR 878.4810.