Dalphene Index

Devices linked to volume & folds

Derived area

18 products · matched by keyword rule, not the cleared indication

Filters

Category

FDA pathwayCleared vs approvedCleared means the FDA agreed a device resembles one already on sale, while approved means the FDA read the maker's own clinical evidence and accepted it, so the two words describe different amounts of review and are not interchangeable.510(k) = cleared

Manufacturer5

Evidenceper modality

EU registerpresence only

Narrows to products we matched in EUDAMED. There is no opposite filter.

18 products

Merz North America, Inc. · Injectables

PMA · approvedP090016
Approved2011Studies1,298Trials46

Merz North America, Inc. · Injectables

PMA · approvedP250016
Approved2026Studies1,298Trials46

Merz North America, Inc. · Injectables

PMA · approvedP250020
Approved2026Studies1,298Trials46

Allergan · Injectables

PMA · approvedP050047
Approved2010Studies1,298Trials46

Allergan · Injectables

PMA · approvedP110033
Approved2016Studies1,298Trials46

Allergan · Injectables

PMA · approvedP110033
Approved2017Studies1,298Trials46

Allergan · Injectables

PMA · approvedP110033
Approved2013Studies1,298Trials46

Allergan · Injectables

PMA · approvedP110033
Approved2022Studies1,298Trials46

Maker · Injectables

No US authorization
DecisionStudies1,298Trials46

Merz North America, Inc. · Injectables

PMA · approvedP050037
Approved2006Studies582Trials7

Q-Med AB · Injectables

PMA · approvedP140029EU
Approved2016Studies1,298Trials46

Q-Med AB · Injectables

PMA · approvedP140029EU
Approved2020Studies1,298Trials46

Q-Med AB · Injectables

PMA · approvedP040024EU
Approved2015Studies1,298Trials46

Q-Med AB · Injectables

PMA · approvedP040024
Approved2014Studies1,298Trials46

Prollenium Medical Technologies, Inc. · Injectables

PMA · approvedP160042
Approved2017Studies1,298Trials46

Teoxane S.A. · Injectables

PMA · approvedP170002
Approved2017Studies1,298Trials46

Q-Med AB · Injectables

PMA · approvedP030050EU
Approved2004Studies586Trials17

Allergan · Injectables

PMA · approvedP110033
Approved2023Studies1,298Trials46

Curated seed list; study and trial counts are per modality, not per brand.

Sorted by most recent FDA decision — a filing date, not a quality signal.

How each product matched (18)
ProductMatched termSource string
Belotero Balancenasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Belotero Intense (+) Lidocainenasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Belotero Volume (+) Lidocainenasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Juvederm Ultra XCnasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Juvederm Volbella XCnasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Juvederm Vollure XCnasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Juvederm Voluma XCnasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Juvederm Volux XCnasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Profhilonasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Radiessenasolabial foldClinicalTrials.gov condition query for Calcium hydroxylapatite filler
Restylane Defynenasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Restylane Kyssenasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Restylane Lyftnasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Restylane Silknasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Revanesse Versanasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
RHA Collectionnasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler
Sculptranasolabial foldClinicalTrials.gov condition query for Poly-L-lactic acid collagen stimulator
SKINVIVE by Juvedermnasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler

Derived by keyword rule from real source strings, not the cleared indication.