FDA product code LPO: Gases Used Within Eye To Place Pressure On Detached Retina
LPO is the FDA product code for gases used within eye to place pressure on detached retina. It is a Class III device, regulated under 21 CFR 886.4270 and reviewed by the Ophthalmic panel. Devices under LPO reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 1 recall for LPO devices.
Classification
| Field | Value |
|---|---|
| Device name | Gases Used Within Eye To Place Pressure On Detached Retina |
| Device class | Class III |
| Regulation | 21 CFR 886.4270 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
Recalls for LPO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-11-18.
Frequently asked questions
What is FDA product code LPO?
LPO is the FDA product code for gases used within eye to place pressure on detached retina. It is a Class III device, regulated under 21 CFR 886.4270 and reviewed by the Ophthalmic panel.
What device class is LPO?
Class III, regulation 21 CFR 886.4270. Typical premarket route: PMA.
Have LPO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-11-18.
Next steps
- Run an FDA pathway report with predicate devices for product code LPO
- Run a recall and safety report across every LPO manufacturer
- Watch product code LPO 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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