Maker —
No US authorization
Decision—Studies450Trials49
Bellafill — FDA approval record and published evidence
Tiger Aesthetics Medical, LLC · Injectables
PMA · approvedP020012
PathwayPathwayA PMA is a premarket approval. FDA reviewed the manufacturer's own clinical evidence and approved the product for the indication it reviewed. It is an approval, and it covers that specific product and indication.
Methodology →PMA · approved
Methodology →PMA · approved
ClassClassThe FDA classification record for this product's code was not fetched, so the class is not transcribed here.
Methodology →—
Methodology →—
First approved2006
Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else.
Methodology →20
Methodology →20
StudiesStudiesPubMed records for a fixed query about the MODALITY, not the brand. It measures how much has been published about a technique. It is not a quality score, not an efficacy measure, not a count of randomised trials, and not comparable between modalities of different ages. It says nothing about this brand specifically.
Methodology →—
Methodology →—
TrialsTrialsClinicalTrials.gov studies for a fixed query about the MODALITY, not the brand. Registration is not completion, not publication and not a result. Counts include studies of any status, size or sponsor, and the recruiting figure is a snapshot taken on the run date. Device studies are under-registered relative to drug studies.
Methodology →—
Methodology →—
A PMA product is approved, not cleared — FDA read the maker's own evidence. What this measuresA PMA is a premarket approval. FDA reviewed the manufacturer's own clinical evidence and approved the product for the indication it reviewed. It is an approval, and it covers that specific product and indication. It measures how much has been published about a technique. It is not a quality score, not an efficacy measure, not a count of randomised trials, and not comparable between modalities of different ages. It says nothing about this brand specifically.
Methodology →
Overview
- Modality
- —
- Manufacturer
- Tiger Aesthetics Medical, LLC
- Category
- Injectables
- Latest decision
- FDA records
- 38
- Mapping
- Verified
Mapping is the weakest link on this page; the rule is published. What this measures38 openFDA PMA record(s) match. Records were selected by fetching every openFDA PMA record filed under P020012 (limit=1000, the complete supplement set) and keeping those whose trade_name contains 'bellafill' once accents and punctuation are folded away. Folding is required because FDA writes the registered mark inline on many supplements ("Restylane® Defyne", "Juvéderm® Ultra XC"), and a literal phrase search silently skips those records. An ORIGINAL PMA record under this trade name exists, so first_decision_date is that original decision date; latest_decision_date is the most recent matching supplement. P020012 carries 43 records in total; 38 of them name this brand. Sibling products approved under the same PMA are carded separately and are not deduplicated by PMA number. A mapping is the weakest link on this page: if it is wrong, every number above it is about the wrong product. It is stated in full so it can be checked.
Methodology →
Regulatory
| Identifier | Type | Role | FDA record |
|---|---|---|---|
| P020012 | PMA — approved | Primary | Open → |
| Code | FDA device name | 21 CFR |
|---|---|---|
| LMH | — | — |
Approved indication: not transcribed here — read it on P020012 → Approved indicationopenFDA's release of this database does not return the indications-for-use text, and this Index will not paraphrase a regulatory statement it has not transcribed. A PMA is a premarket approval. FDA reviewed the manufacturer's own clinical evidence and approved the product for the indication it reviewed. It is an approval, and it covers that specific product and indication.
Methodology →
Evidence
No modality is assigned to this product, so no literature or trial counts are shown.
Treatment areas
No treatment area could be derived: neither the modality's condition query nor the FDA product codes contained a term on the keyword list.
Sources
- openFDA query run for this producthttps://api.fda.gov/device/pma.json?search=pma_number:%22P020012%22&limit=1000
- openFDA query run for this producthttps://api.fda.gov/device/classification.json?search=product_code:%22LMH%22&limit=1
- FDA public record for P020012https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020012
No adverse-event data is published anywhere on this site. What this measuresNo adverse-event data appears anywhere on this site. MAUDE and FAERS were never queried: those counts have no denominator, reporting is voluntary and duplicated, and a report is not evidence of causation. Publishing them beside a brand name would mislead.
Methodology →