Data / Medical devices / United States / Galderma Laboratories, L.P.
Galderma Laboratories, L.P.: FDA-registered device maker in Fort Worth, TX, United States, 1 510(k) clearance and 3 PMA approvals
Galderma Laboratories, L.P. is registered with the FDA (registration 1000118068) in Fort Worth, TX, United States. It lists 4 device types. The FDA files 1 510(k) clearance and 3 PMA approvals under its listings, the newest dated December 9, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1000118068
- Address
- 14600 Heritage Pkwy, Fort Worth, TX, United States, 76177
- Owner or operator
- Galderma Laboratories, L.P. (10047852)
- Roles
- Complaint file establishment
- First device listed
- November 7, 2014
- Registered through
- 2027
- Brand names listed
- Cetaphil Fast Rescue Pimple Patch, Differin Acne-Prone Skin Patches, Differin Power Patch Fast Fix, Differin Power Patch Skin Restore, Perlane, Restylane, Restylane Contour, Restylane Defyne and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment | accessdata.fda.gov |
| Implant, Dermal, For Aesthetic Use | LMH | 3 | Complaint file establishment | accessdata.fda.gov |
| Implant, Dermal, For Aesthetic Use In The Hands | PKY | 3 | Complaint file establishment | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 9, 2011 | K110850 | K-PACK II NEEDLE- 27G & 30G THIN WALL | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 9, 2016 | P140029 | Restylane Refyne, Restylane Defyne | LMH | 51 | September 18, 2026 | accessdata.fda.gov |
| March 25, 2005 | P040024 | RESTYLANE INJECTABLE GEL | LMH | 132 | March 12, 2026 | accessdata.fda.gov |
| August 3, 2004 | P030050 | SCULPTRA AND SCULPTRA AESTHETIC | LMH | 54 | September 17, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Implant, Dermal, For Aesthetic Use
- All makers of Dressing, Wound, Occlusive
- All makers of Implant, Dermal, For Aesthetic Use In The Hands
Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.