Exact product record

Restylane Eyelight

Galderma · Prescription hyaluronic acid dermal filler

Trusted product98
FDA approval record
Regulatory statusFDA approved prescription deviceP040024/S135 · Approved 2023-05-08
Approved useImprovement of infraorbital hollowingAdults over age 21
MaterialTemporary hyaluronic acid gelCrosslinked hyaluronic acid gel with BDDE and 0.3% lidocaine
Independent trust review · spa-trust-1.0

Trusted product

This product record passed every critical evidence and disclosure gate.

98of 10085 required
5/5 gates passedReviewed Jul 13, 2026Valid until Jan 9, 2027
See validation gates and evidence
Exact product identified

The record identifies Restylane Eyelight rather than inferring from the broader Restylane family.

Required gate · 1 receipt
pass
Regulatory status verified

FDA PMA supplement P040024/S135 is attached.

Required gate · 2 receipts
pass
Approved indication bounded

The record limits the approved use to improvement of infraorbital hollowing in adults over 21.

Required gate · 1 receipt
pass
Safety labeling attached

Patient labeling, clinician directions, contraindications, and serious risk guidance are attached.

Required gate · 3 receipts
pass
Current source review

Regulatory and study evidence was reviewed within the active trust window.

Required gate · 6 receipts
pass
Exact product identity100

Manufacturer, composition, approval supplement, route, and indication are explicit.

Regulatory verification100

The FDA approval page and PMA materials are attached.

Labeling completeness98

Clinician directions and patient labeling are included.

Product-specific evidence96

The pivotal evidence is tied to the exact product and approved indication.

Safety disclosure98

Contraindications, expected reactions, rare serious risks, and emergency signs are preserved.

Source traceability96

Every trust claim resolves to a regulator or peer-reviewed receipt.

Evidence receipts

Restylane Eyelight Summary of Safety and Effectiveness DataU.S. Food and Drug Administration · regulator100%Restylane Eyelight - P040024/S135U.S. Food and Drug Administration · regulator100%Restylane Eyelight Patient LabelingU.S. Food and Drug Administration · regulator100%Restylane Eyelight Directions for UseU.S. Food and Drug Administration · regulator100%Dermal Fillers (Soft Tissue Fillers)U.S. Food and Drug Administration · regulator100%Safety and Effectiveness of Restylane Eyelight for Infraorbital HollowingAesthetic Surgery Journal · peer reviewed96%

What this does not mean

  • FDA approval does not make this product appropriate for every under-eye concern or every person.
  • Product trust does not validate a clinic's inventory, injector, technique, price, or outcome history.
  • The approval and pivotal evidence apply to the exact product and approved indication, not every under-eye filler.

What is verified

The pivotal study showed a large improvement over no treatment for selected adults with infraorbital hollowing.

Manufacturer
Galderma
Administration
Injected under the eye between the lower eyelid and cheekbone by a trained medical professional
Access
Prescription device administered by a trained medical professional

Safety boundary

Study-related adverse events were reported in 12.7% of treated participants and were usually mild; rare serious filler complications remain clinically important even when uncommon.

Common and expected

  • Swelling
  • Bruising
  • Tenderness
  • Redness
  • Pain or soreness
  • Temporary firmness or small lumps

Rare but serious

  • Unintentional injection into a blood vessel
  • Skin injury or tissue death
  • Vision abnormalities including blindness
  • Stroke

Not interchangeable

  • FDA approval does not make this product appropriate for every under-eye concern or every person.
  • Product trust does not validate a clinic's inventory, injector, technique, price, or outcome history.
  • The approval and pivotal evidence apply to the exact product and approved indication, not every under-eye filler.

Do not use

  • History of anaphylaxis or multiple severe allergies identified in the product labeling
  • Known allergy to gram-positive bacterial proteins
  • Known allergy to lidocaine or amide-type local anesthetics
See candidacy, outcomes, care, and alternatives
Source ledger

6 product receipts

Restylane Eyelight Summary of Safety and Effectiveness DataU.S. Food and Drug Administration · Reviewed 2026-07-13Restylane Eyelight - P040024/S135U.S. Food and Drug Administration · Reviewed 2026-07-13Restylane Eyelight Patient LabelingU.S. Food and Drug Administration · Reviewed 2026-07-13Restylane Eyelight Directions for UseU.S. Food and Drug Administration · Reviewed 2026-07-13Dermal Fillers (Soft Tissue Fillers)U.S. Food and Drug Administration · Reviewed 2026-07-13Safety and Effectiveness of Restylane Eyelight for Infraorbital HollowingAesthetic Surgery Journal · Reviewed 2026-07-13