Dalphene Index

Restylane Lyft — FDA approval record and published evidence

Q-Med AB · Injectables · Hyaluronic acid filler

PMA · approvedPMAPremarket approval: the FDA's most demanding device review, in which the company has to hand over its own clinical evidence that the device is safe and does what it claims.P040024
PathwayPMA · approved
Class
First approved2015
Years on market11
Studies1,298
Trials46

A PMA product is approved, not cleared — FDA read the maker's own evidence.

Shares treatment areas — not a recommendation.

Overview

ModalityModalityA family of treatments that work the same way — such as radiofrequency microneedling, or lasers that leave the skin surface intact — rather than any one branded machine.
Hyaluronic acid filler
Manufacturer
Q-Med AB
Category
Injectables
Latest decision
FDA records
18
MappingCrosswalkThe mapping this site keeps between records that no single source links up, such as tying a brand name to the FDA codes and the study searches that describe the same thing.
Verified

Mapping is the weakest link on this page; the rule is published.

Regulatory

Identifiers on file, copied from the openFDA response. Each links to its FDA public record.
IdentifierTypeRoleFDA record
P040024PMA — approvedPrimaryOpen →
FDA product codes on the matched records.
CodeFDA device name21 CFR
LMH
PKY

Approved indication: not transcribed here — read it on P040024 →

EUDAMEDEUDAMEDThe European Union's public database where devices and their makers are listed, so an entry there records that a device exists in the European system and is not any kind of approval or clearance.Also registered in the EU
Listed as
Restylane Lyft Lidocaine
Manufacturer
Q-Med AB
Basic UDI-DIBasic UDI-DIThe European reference for a whole family of devices that share the same purpose and design, so several sizes or models sit under one of these.
B-012129LD
UDI-DIUDI-DIThe European reference for one specific model, size or configuration of a device.
D-012129LD
Risk classRisk classEurope's own risk grouping for devices, which runs from I to III and does not line up one-to-one with the FDA's classes.
Class III
Status in EUDAMED
On the market

Registered in EUDAMED, the EU device database. A registration, not an approval.

Evidence

Counted for the modality, never the brand.

1,298PubMed, all time
1,033PubMed, 10y
46Studies
3Recruiting
Hyaluronic acid filler — PubMed records per year, 2016–2026 (2026 partial)
Hyaluronic acid filler
201644
201755
201864
201980
2020110
2021119
2022114
2023128
2024164
2025196
2026120
196papers · 2025 · modality, not brand+20%

PubMed counts publications; ClinicalTrials.gov counts registrations. Neither is a quality score.

What that literature is made of

By publication type · all years

All records on this querythe set every row below is drawn from1,299
Systematic review / meta-analysis3.2% of the total41
Randomised controlled trial12.5% of the total162
Clinical trial (any type)16.1% of the total209
Review14.6% of the total190
Case report14.9% of the total193
Hyaluronic acid filler — PubMed records by publication type, all years
PubMed records
All records on this query1,299
Systematic review / meta-analysis41
Randomised controlled trial162
Clinical trial (any type)209
Review190
Case report193

Each row is one publication typePublication typeThe label the literature index attaches to a paper to say what kind of work it is, which is assigned by the index rather than by this site., and the rows overlap: PubMed explodes Clinical trial, so it already contains the randomised trials, and the systematic-review subset intersects Review. They do not sum to the total. Bar length is the count against this modality's own query total; rows are in the order the source file defines them, not by size.

What each modality's PubMed total is made of, by publication type. Counting study types is not a quality assessment.

PubMed query, verbatim

("hyaluronic acid filler"[tiab] OR "hyaluronic acid dermal filler"[tiab] OR ("hyaluronic acid"[tiab] AND ("dermal filler"[tiab] OR "soft tissue filler"[tiab] OR "nasolabial"[tiab] OR "lip augmentation"[tiab] OR "midface"[tiab]))) AND (aesthetic[tiab] OR cosmetic[tiab] OR facial[tiab] OR skin[tiab] OR volume[tiab])

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ClinicalTrials.gov query, verbatim

intervention: ("hyaluronic acid filler" OR "hyaluronic acid dermal filler" OR "HA filler") condition: ("nasolabial folds" OR "facial wrinkles" OR "lip augmentation" OR "volume deficit" OR cosmetic)

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Treatment areas

What matched, and where
AreaMatched termSource string
Wrinkles & lineswrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Volume & foldsnasolabial foldClinicalTrials.gov condition query for Hyaluronic acid filler

Derived by keyword rule, not the cleared or approved indication.

Sources

No adverse-event data is published anywhere on this site.