FDA product code PUE: Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
PUE is the FDA product code for biomicroscope, slit-lamp, ac-powered, exempt. It is a Class II device, regulated under 21 CFR 886.1850 and reviewed by the Ophthalmic panel. Devices under PUE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code is the class II exempt counterpart of HJO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Classification
| Field | Value |
|---|---|
| Device name | Biomicroscope, Slit-Lamp, Ac-Powered, Exempt |
| Device class | Class II |
| Regulation | 21 CFR 886.1850 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for PUE devices
openFDA lists no recalls for product code PUE.
Frequently asked questions
What is FDA product code PUE?
PUE is the FDA product code for biomicroscope, slit-lamp, ac-powered, exempt. It is a Class II device, regulated under 21 CFR 886.1850 and reviewed by the Ophthalmic panel.
What device class is PUE?
Class II, regulation 21 CFR 886.1850. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PUE
- Run a recall and safety report across every PUE manufacturer
- Watch product code PUE for new clearances and recalls
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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