Medcxy

Product dossierBuilt from registrations, label text and platform-curated data

Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine)P160042

Ask about this product

Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine) is a Hyaluronic acid filler product, registered by Prollenium Medical Technologies, Inc.. Linked registrations: US P160042. First approved in US on 2017-08-04 (P160042). Data as of 2026-10-27.

  • Regulatory classHyaluronic acid filler · class not determined
  • HolderProllenium Medical Technologies, Inc.
  • JurisdictionsUS
  • Updated2026-10-27 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine)

Product
Regulatory class
Not determined (no verified registration linked)Could not verify
Category
Hyaluronic acid filler
US · FDA PMA
P160042
Name on registration
REVANESSE ULTRA
Registrant
Prollenium Medical Technologies, Inc.
First approval
2017-08-04
This certificate issued
2017-08-04
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

No data yet

Registration timeline

  1. US

    P160042 first approved

  2. US

    P160042 · P160042/S016

    Normal 180 Day Track｜Change Design/Components/Specifications/Material｜Approval for the qualification of hyaluronic acid (HA) from a new supp…

  3. US

    P160042 · P160042/S026

    Special (Immediate Track)｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for standardizing the descriptive informa…

  4. US

    P160042 · P160042/S024

    135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for the addition of a mixer discharge…

  5. US

    P160042 · P160042/S029

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approval for modifications to cleanroom layout in a secondary manuf…

  6. US

    P160042 · P160042/S031

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜new polyvinyl chloride material used in secondary packaging for Rev…

  7. US

    P160042 · P160042/S032

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval to qualify a Third-Party Logistics (3PL) supplier for ware…

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record.

Cross findings · Price observations

Sign in to see findings and prices

Findings and prices stay out of indexable pages.

Sign in to view

Recent changes

5
  • P160042: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2026-10-14
  • P160042: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜new pol…2026-05-08
  • P160042: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approva…2025-12-22
  • P160042: 135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Pack…2024-08-20
  • P160042: Special (Immediate Track)｜Labeling Change - Indications/instructions/shelf life/…2024-07-12

Sources

1