Data / Medical devices / France / E-Swin

E-Swin: FDA-registered device maker in Houdan Yvelines, France, 1 510(k) clearance

Name: E-Swin FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

E-Swin is registered with the FDA (registration 3014132468) in Houdan Yvelines, France. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 11, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014132468
Address: ZA de la Prevote Rue des Cotes d'Orval, Houdan Yvelines, France, 78550
Owner or operator: E-Swin (10076601)
Roles: Manufacturer
First device listed: July 24, 2020
Registered through: 2026
Brand names listed: E-Eye, tearcheck T

Devices it lists

Device	Product code	Class	Role	Source
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Manufacturer	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Manufacturer	accessdata.fda.gov
Topographer, Corneal, Ac-Powered	MMQ	1	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
June 11, 2020	K200616	E>EyeC	ONF	Substantially Equivalent	E-Swin	accessdata.fda.gov

Compare with other makers

Updated June 11, 2020. 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.