Data / Medical devices / United States / Dermaqual

Dermaqual: FDA-registered device maker in Johnson City, TN, United States, 2 510(k) clearances

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

Dermaqual is registered with the FDA (registration 3017065670) in Johnson City, TN, United States. It lists 4 device types. The FDA files 2 510(k) clearances 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: 3017065670
Address: 153 Cedar Grove Rd, Johnson City, TN, United States, 37601
Owner or operator: Dermaqual (10075699)
Roles: Repackager or relabeler, Specification developer
First device listed: July 8, 2021
Registered through: 2026
Brand names listed: Bioginix, Bioginix Centrifuge, Forza Pen Pro

Devices it lists

Device	Product code	Class	Role	Source
Centrifuge, Hematocrit	GKG	2	Repackager or relabeler	accessdata.fda.gov
Platelet And Plasma Separator For Bone Graft Handling	ORG	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Powered Microneedle Device	QAI	2	Repackager or relabeler, Specification developer	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
December 23, 2015	K151890	Medical Diode Laser Systems	GEX	Substantially Equivalent	Wuhan Gigaa Optronics 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.