Data / Medical devices / United States / Medicol Usa, Inc

Medicol Usa, Inc: FDA-registered device maker in Snellville, GA, United States, 7 510(k) clearances

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

Medicol Usa, Inc is registered with the FDA (registration 3005205318) in Snellville, GA, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 30, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005205318
Address: 2701 Holly Springs Dr, Snellville, GA, United States, 30078
Owner or operator: Medicol USA Inc (10028782)
Roles: Repackager or relabeler
First device listed: December 22, 2010
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Dermatome	GFD	1	Repackager or relabeler	accessdata.fda.gov
Device, Digital Image Storage, Radiological	LMB	1	Repackager or relabeler	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Repackager or relabeler	accessdata.fda.gov
Light, Ultraviolet, Dermatological	FTC	2	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	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
January 30, 2014	K132643	UV PHOTOTHERAPY	FTC	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.	accessdata.fda.gov
April 21, 2013	K123483	DIODE LASER	GEX	Substantially Equivalent	BEIJING SYNTECH LASER CO., LTD.	accessdata.fda.gov
December 14, 2012	K113018	APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM	GEX	Substantially Equivalent	BEIJING SYNTECH LASER CO., LTD.	accessdata.fda.gov
April 19, 2011	K110434	TRIXEL CO2 LASER	GEX	Substantially Equivalent	BEIJING SYNTECH LASER CO., LTD.	accessdata.fda.gov
November 5, 2009	K091568	LH-75 PHOTOTHERAPY SYSTEM	FTC	Substantially Equivalent	Lerner Medical Devices, Inc.	accessdata.fda.gov
February 2, 2009	K083748	IPULSE, MODEL: I150	GEX	Substantially Equivalent	Cyden Limited	accessdata.fda.gov
March 24, 2004	K040156	IFL PROFESSIONAL SYSTEM, MODEL C100	GEX	Substantially Equivalent	Cyden Limited	accessdata.fda.gov

Compare with other makers

Updated January 30, 2014. 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.