FDA product code LMI: Implant, Collagen For Non-Aesthetic Use
LMI is the FDA product code for implant, collagen for non-aesthetic use. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under LMI reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Collagen For Non-Aesthetic Use |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LMI devices
openFDA lists no recalls for product code LMI.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8616 — Microphone for use with cochlear implant device, replacement
- L8617 — Transmitting coil for use with cochlear implant device, replacement
- L8615 — Headset/headpiece for use with cochlear implant device, replacement
- L8629 — Transmitting coil and cable, integrated, for use with cochlear implant device, replacement
- J0888 — Injection, epoetin beta, 1 microgram, (for non esrd use)
Frequently asked questions
What is FDA product code LMI?
LMI is the FDA product code for implant, collagen for non-aesthetic use. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is LMI?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LMI
- Run a recall and safety report across every LMI manufacturer
- Watch product code LMI 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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