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Restylane Kysse Injectable GelP140029

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Restylane Kysse Injectable Gel is a Hyaluronic acid filler product, registered by Q-Med AB. Linked registrations: US P140029. First approved in US on 2016-12-09 (P140029). Data as of 2026-10-19.

  • Regulatory classHyaluronic acid filler · class not determined
  • HolderQ-Med AB
  • JurisdictionsUS
  • Updated2026-10-19 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

Restylane Kysse Injectable Gel

Product
Regulatory class
Not determined (no verified registration linked)Could not verify
Category
Hyaluronic acid filler
US · FDA PMA
P140029
Name on registration
Restylane Refyne, Restylane Defyne
Registrant
Q-Med AB
First approval
2016-12-09
This certificate issued
2016-12-09
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

No data yet

Registration timeline

  1. US

    P140029 first approved

  2. US

    P140029 · P140029/S051

    Normal 180 Day Track｜Change Design/Components/Specifications/Material｜Approval for (1) a new plastic syringe and new plunger, new plunger ro…

  3. US

    P140029 · P140029/S055

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approval for modifications to the Water for Injection (WFI) system

  4. US

    P140029 · P140029/S054

    Panel Track｜Change Design/Components/Specifications/Material｜Approval for expanding the indications of Restylane Contour for correction of t…

  5. US

    P140029 · P140029/S056

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for extension of shelf life for the raw material sodium hy…

  6. US

    P140029 · P140029/S057

    Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜Approval for the post-approval study protocol to evaluate the safety of re-trea…

  7. US

    P140029 · P140029/S058

    Normal 180 Day Track No User Fee｜Labeling Change - PAS｜approval for updated device labeling, including the addition of a statement regarding…

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record.

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Recent changes

5
  • P140029: Normal 180 Day Track No User Fee｜Labeling Change - PAS｜approval for updated devi…2026-09-18
  • P140029: Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜Approval for the po…2026-05-15
  • P140029: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2026-04-14
  • P140029: Panel Track｜Change Design/Components/Specifications/Material｜Approval for expand…2026-03-20
  • P140029: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approva…2025-09-26

Sources

1