510(k) Report

FDA applicant

Prollenium Medical Technologies, Inc.

Aurora1 decision2017–20171 recall

FDA records 1 decision for Prollenium Medical Technologies, Inc. (Aurora) in 2017: 1 original PMA approval. All are in product code LMH (Implant, Dermal, For Aesthetic Use). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Prollenium Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2017high 1 (2018) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Prollenium Medical Technologies, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LMHImplant, Dermal, For Aesthetic Use1decision

What has FDA decided for it lately?

  • P160042Revanesse UltraProllenium Medical Technologies, Inc. · 20171 recall

The one decision as Prollenium Medical Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • P160042Revanesse Versa, PN40081Nov 15, 2018Class II