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Revanesse Versa 1.0mL

Prollenium Medical · Model 40081 · UDI-DI 10669808001007

Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Revanesse Versa is manufactured by Prollenium Medical Technologies, and is a biocompatible, sterile, injectable hydrogel based on bioresorbable cross-linked hyaluronan (HA) (22 – 28 mg / mL concentration). The gel is delivered in a pre-filled disposable glass syringe. Each box of Revanesse Versa contains two 1.0 mL syringes of Revanesse Versa along with two sterile needles. Revanesse Versa is injected by qualified, trained doctors into the dermis of patients, using a variety of techniques. The injections place a small portion of the gel beneath a crease or wrinkle in the skin and the augmentation of the tissue produces a smoothing effect on the surface.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.