FDA product code QHF: Energy Based Device For Treatment Of Tattoos

QHF is the FDA product code for energy based device for treatment of tattoos. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. Devices under QHF reach the market by 510(k); FDA lists no cleared 510(k)s for it.

Definition

To reduce formation of bubbles during laser treatment of tattoos

Classification

FieldValue
Device nameEnergy Based Device For Treatment Of Tattoos
Device classClass II
Regulation21 CFR 878.4810
Review panelSU — General and Plastic Surgery
Medical specialtyGeneral, Plastic Surgery
Premarket route510(k)

Recalls for QHF devices

openFDA lists no recalls for product code QHF.

Frequently asked questions

What is FDA product code QHF?

QHF is the FDA product code for energy based device for treatment of tattoos. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel.

What device class is QHF?

Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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