Skip to content

Bellafill Permanent Dermal Filler

by Tiger Aesthetics Medical, LLC

PMA P020012

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P020012↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP020012 Date27 Oct 2006ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Bellafill Dermal Filler
Trade Name
Artefill, Bellafill Pmma Collagen Permanent Dermal Filler
Generic Name
Implant, dermal, for aesthetic use
PMA Number
FDA Product Code
LMH
Device Class
Class III
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Bellafill is a dermal implant classified as an Implant, Dermal, For Aesthetic Use, designed for the correction of nasolabial folds. It consists of a collagen matrix combined with polymethylmethacrylate (PMMA) microspheres, providing a semi-permanent volume restoration to improve facial contour and soft tissue defects.

The device is supplied as a sterile, single-use product and is intended for subcutaneous injection by trained professionals in clinical settings. It requires no special storage conditions beyond refrigeration prior to use and is regulated under an FDA PMA (Pre-Market Approval). Approval was granted for aesthetic use, including correction of nasolabial folds, with no MRI safety restrictions specified.

Other devices from Tiger Aesthetics Medical, LLC