FDA product code LMH: Implant, Dermal, For Aesthetic Use

LMH is the FDA product code for implant, dermal, for aesthetic use. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under LMH reach the market by PMA; FDA lists no cleared 510(k)s for it. 22 PMA applications cite this product code. FDA has posted 7 recalls for LMH devices.

Classification

Recalls for LMH devices

7 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-11-15.

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
• L8615 — Headset/headpiece for use with cochlear implant device, replacement
• L8617 — Transmitting coil for use with cochlear implant device, replacement
• L8618 — Transmitter cable for use with cochlear implant device or auditory osseointegrated device, replacement
• L8622 — Alkaline battery for use with cochlear implant device, any size, replacement, each

Frequently asked questions

What is FDA product code LMH?

LMH is the FDA product code for implant, dermal, for aesthetic use. It is a Class III device, reviewed by the General and Plastic Surgery panel.

What device class is LMH?

Class III. Typical premarket route: PMA.

Have LMH devices been recalled?

Yes: 7 product recalls across 7 recall events; the most recent began 2018-11-15.

Next steps

• Run an FDA pathway report with predicate devices for product code LMH
• Run a recall and safety report across every LMH manufacturer
• Watch product code LMH 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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