PYUClass I

Sponge, Eyelid Cleaning, Powered

21 CFR 878.4820 / General, Plastic Surgery

PYU is the FDA product code for Sponge, Eyelid Cleaning, Powered, a class I device type, regulated under 21 CFR 878.4820. FDA's definition for this code reads: "This device type is intended to cleanse the eyelid margins and eyelashes by a healthcare professional". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PYU
Device name: Sponge, Eyelid Cleaning, Powered
FDA definition: This device type is intended to cleanse the eyelid margins and eyelashes by a healthcare professional.
Regulation: 21 CFR 878.4820
Device class: Class I
Review panel: General, Plastic Surgery
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PYU

FDA records hold no clearances under product code PYU.

Recent recalls

Product code PYU

FDA records show no recalls under product code PYU.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)