Data / Medical devices / Costa Rica / Establishment Labs S.A.

Establishment Labs S.A.: FDA-registered device maker in Coyol Alajuela, Costa Rica, 2 510(k) clearances and 1 PMA approval

Name: Establishment Labs S.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Establishment Labs S.A. is registered with the FDA (registration 3012883202) in Coyol Alajuela, Costa Rica. It lists 4 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated September 26, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012883202
Address: Coyol Free Zone & Business Park Building 4th Street, Building B-15, Coyol Alajuela, Costa Rica, 20113
Owner or operator: Establishment Labs- Motiva USA LLC (10061559)
Roles: Complaint file establishment, Manufacturer
First device listed: October 29, 2019
Registered through: 2027
Brand names listed: Intraoperative, Single-Use, Sterile, Silicone Breast Sizers Motiva Implant Matrix®, Motiva Flora SmoothSilk Tissue Expander, Motiva Inflatable Balloon, Motiva SmoothSilk Round and SmoothSilk Ergonomix Breast Implants

Devices it lists

Device	Product code	Class	Role	Source
Expander, Surgical, Skin Graft	FZW	1	Manufacturer	accessdata.fda.gov
Mammary Sizer	MRD	U	Manufacturer	accessdata.fda.gov
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled	FTR	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Tissue Expander And Accessories	LCJ	U	Manufacturer	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
October 13, 2023	K211676	Motiva Flora SmoothSilk Tissue Expander	LCJ	Substantially Equivalent	Motiva USA, LLC	accessdata.fda.gov
February 5, 2019	K183163	Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix	MRD	Substantially Equivalent	Motiva USA, LLC	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
September 26, 2024	P230005	Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas	FTR	4	October 2, 2026	accessdata.fda.gov

Compare with other makers

Updated October 2, 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.