Maker —
No US authorization
Decision—Studies450Trials49
Elravie Re2O — no US marketing authorization found
Maker — · Injectables · Human acellular dermal matrix (ECM) booster
No US authorization
PathwayPathwayThe FDA device, PMA and drug records were searched for this brand and for its manufacturer, and no record carries it. This is a checked absence, not an unchecked one: the queries that were run are listed on the product's page. It is a statement about the US record on the run date. It is not a safety finding, and it says nothing about the product's status in any other country.
Methodology →No US authorization
Methodology →No US authorization
ClassClassNo US record carries this brand, so there is no product code to read a device class from.
Methodology →—
Methodology →—
First decision—
Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else.
Methodology →—
Methodology →—
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 →158
Methodology →158
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 →106
Methodology →106
No US authorization found — the records were searched, not left unchecked. What this measuresThe FDA device, PMA and drug records were searched for this brand and for its manufacturer, and no record carries it. This is a checked absence, not an unchecked one: the queries that were run are listed on the product's page. It is a statement about the US record on the run date. It is not a safety finding, and it says nothing about the product's status in any other country. 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 →
Shares treatment areas — not a recommendation. What this measuresPicked mechanically, by rule and nothing else: products in the same Index category that share the most derived treatment areas with this one, ties broken alphabetically. Treatment areas are themselves derived by a published keyword rule run over a real source string, not copied from the cleared or approved indication, so a shared area means two products' source strings happened to use the same word. It does not mean the two products do the same job, it is not a claim that they are interchangeable, and it is not a recommendation.
Methodology →
Overview
- Modality
- Human acellular dermal matrix (ECM) booster
- Manufacturer
- —
- Category
- Injectables
- Latest decision
- —
- FDA records
- —
- Mapping
- Not verified
Mapping is the weakest link on this page; the rule is published. What this measuresSearched openFDA for a 510(k), a PMA and a drug-label record under this brand name; all three returned zero results on the run date, as did the same searches for 'Re2O' alone and applicant searches for L&C Bio and Humedix. The product is made by L&C Bio Co., Ltd. and distributed in South Korea by Humedix under the Elravie brand, so the two companies play different roles; the rest of the Elravie line is crosslinked hyaluronic acid and is a different kind of product. L&C Bio lists Re2O under human tissue rather than under medical devices. 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
No US authorization
No clearance number, approval number, device class or decision date is shown, because the FDA device, PMA and drug records were searched for this brand and for its manufacturer and none of them carries it. The queries that were run are listed under Sources on this page, so the absence can be re-checked rather than taken on trust. This describes the US public record on the run date. It is not a safety finding, and the product may be authorised in other countries.
US indication: none shown, because no US record carries this brand, so FDA has assessed no indication for it. US indicationThe FDA device, PMA and drug records were searched for this brand and for its manufacturer, and no record carries it. This is a checked absence, not an unchecked one: the queries that were run are listed on the product's page. It is a statement about the US record on the run date. It is not a safety finding, and it says nothing about the product's status in any other country.
Methodology →
Evidence
Counted for the modality, never the brand.
158PubMed, all time
112PubMed, 10y
106Studies
12Recruiting
PubMed counts publications; ClinicalTrials.gov counts registrations. Neither is a quality score. What this measuresPubMed record counts and ClinicalTrials.gov study counts for a fixed query about the MODALITY, never 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. 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. The same counts apply to every other product in the Index on this modality: CellREDM, Juveacell.
Methodology →
PubMed query, verbatim
("acellular dermal matrix"[tiab] OR "acellular dermis"[tiab] OR "dermal matrix"[tiab]) AND (injectable[tiab] OR inject*[tiab] OR micronized[tiab] OR particulate*[tiab] OR powder*[tiab]) AND (skin[tiab] OR dermal[tiab] OR rejuvenation[tiab] OR aesthetic*[tiab])
ClinicalTrials.gov query, verbatim
intervention: ("acellular dermal matrix" OR "acellular dermis" OR "extracellular matrix") condition: (skin OR rejuvenation OR wrinkles OR "skin quality" OR photoaging)
Treatment areas
What matched, and where
| Area | Matched term | Source string |
|---|---|---|
| Wrinkles & lines | wrinkle | ClinicalTrials.gov condition query for Human acellular dermal matrix (ECM) booster |
| Photoaging & rejuvenation | photoaging | ClinicalTrials.gov condition query for Human acellular dermal matrix (ECM) booster |
Derived by keyword rule, not the cleared or approved indication. What this measuresTreatment areas are DERIVED, not copied from an FDA field. A fixed keyword list is run over two real strings: the ClinicalTrials.gov condition query actually executed for this product's modality on the run date, and the device names of the FDA product codes attached to this product's records. The words "skin" and "cosmetic" are ignored because every query contains one of them. An area is not the cleared or approved indication — openFDA's 510(k) response does not carry the indications-for-use text, and this Index does not paraphrase it.
Methodology →
Sources
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=device_name:"Elravie%20Re2O"&limit=1
- openFDA query run for this producthttps://api.fda.gov/device/pma.json?search=trade_name:"Elravie%20Re2O"&limit=1
- openFDA query run for this producthttps://api.fda.gov/drug/label.json?search=openfda.brand_name:"Elravie%20Re2O"&limit=1
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=device_name:"Re2O"&limit=1
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=applicant:"L%26C%20Bio"&limit=1
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=applicant:"Humedix"&limit=1
- PubMed count, all timehttps://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi?db=pubmed&retmode=json&rettype=count&term=%28%22acellular%20dermal%20matrix%22%5Btiab%5D%20OR%20%22acellular%20dermis%22%5Btiab%5D%20OR%20%22dermal%20matrix%22%5Btiab%5D%29%20AND%20%28injectable%5Btiab%5D%20OR%20inject%2A%5Btiab%5D%20OR%20micronized%5Btiab%5D%20OR%20particulate%2A%5Btiab%5D%20OR%20powder%2A%5Btiab%5D%29%20AND%20%28skin%5Btiab%5D%20OR%20dermal%5Btiab%5D%20OR%20rejuvenation%5Btiab%5D%20OR%20aesthetic%2A%5Btiab%5D%29
- PubMed count, last 10 yearshttps://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi?db=pubmed&retmode=json&rettype=count&term=%28%22acellular%20dermal%20matrix%22%5Btiab%5D%20OR%20%22acellular%20dermis%22%5Btiab%5D%20OR%20%22dermal%20matrix%22%5Btiab%5D%29%20AND%20%28injectable%5Btiab%5D%20OR%20inject%2A%5Btiab%5D%20OR%20micronized%5Btiab%5D%20OR%20particulate%2A%5Btiab%5D%20OR%20powder%2A%5Btiab%5D%29%20AND%20%28skin%5Btiab%5D%20OR%20dermal%5Btiab%5D%20OR%20rejuvenation%5Btiab%5D%20OR%20aesthetic%2A%5Btiab%5D%29%20AND%20%28%222016/01/01%22%5Bdp%5D%20%3A%20%222026/12/31%22%5Bdp%5D%29
- ClinicalTrials.gov, all studieshttps://clinicaltrials.gov/api/v2/studies?query.intr=%28%22acellular+dermal+matrix%22+OR+%22acellular+dermis%22+OR+%22extracellular+matrix%22%29&query.cond=%28skin+OR+rejuvenation+OR+wrinkles+OR+%22skin+quality%22+OR+photoaging%29&countTotal=true&pageSize=1
- ClinicalTrials.gov, recruiting onlyhttps://clinicaltrials.gov/api/v2/studies?query.intr=%28%22acellular+dermal+matrix%22+OR+%22acellular+dermis%22+OR+%22extracellular+matrix%22%29&query.cond=%28skin+OR+rejuvenation+OR+wrinkles+OR+%22skin+quality%22+OR+photoaging%29&countTotal=true&pageSize=1&filter.overallStatus=RECRUITING
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 →