# P160042: Revanesse Ultra

- Pathway: PMA
- Applicant: Prollenium Medical Technologies, Inc.
- Decided: Aug 4, 2017 after 316 days
- Product code: LMH (Implant, Dermal, For Aesthetic Use)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 15, 2018 · Class II · Z-1146-2020: Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.

Source page: https://510kreport.com/device/P160042
Methodology: https://510kreport.com/methodology