FDA product code · General hospital

Lice Removal Kit Containing A Solution

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

PUNClass I21 CFR 880.5960510(k) exempt0 decisions0 recalls

FDA lists PUN as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 880.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

To remove lice eggs from hair

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 hospital panel

Twenty years of PUN 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.

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

Planning a device in PUN? 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 880.5960.

LJL Detectors And Removers, Lice, (Including Combs)