Data / Medical devices / United States / So Esthetics

So Esthetics: FDA-registered device maker in Chandler, AZ, United States, 1 510(k) clearance

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

So Esthetics is registered with the FDA (registration 3015610860) in Chandler, AZ, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 11, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015610860
Address: 7400 W Detroit St Suite 160, Chandler, AZ, United States, 85226
Owner or operator: SO Esthetics (10061072)
Roles: Repackager or relabeler
First device listed: August 11, 2019
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Repackager or relabeler	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Repackager or relabeler	accessdata.fda.gov
Platelet And Plasma Separator For Bone Graft Handling	ORG	2	Repackager or relabeler	accessdata.fda.gov
Powered Microneedle Device	QAI	2	Repackager or relabeler	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
August 11, 2023	K230420	Dr. pen Microneedling System	QAI	Substantially Equivalent	Guangzhou Ekai Electronic Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 11, 2023. 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.