Data / Medical devices / United States / Zian Medical, LLC.

Zian Medical, LLC.: FDA-registered device maker in Clearwater, FL, United States, 5 510(k) clearances

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

Zian Medical, LLC. is registered with the FDA (registration 3026540840) in Clearwater, FL, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 23, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3026540840
Address: 1245 Rogers St, Clearwater, FL, United States, 33756
Owner or operator: Zian Medical, LLC. (10087418)
Roles: Repackager or relabeler
First device listed: February 24, 2023
Registered through: 2026
Brand names listed: Allegra, ClearLaze Pico, Luxion, ReviVa, TrimLaze

Devices it lists

Device	Product code	Class	Role	Source
Laser For Disruption Of Adipocyte Cells For Aesthetic Use	PKT	2	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	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 23, 2022	K220268	Picosecond Laser System (Model PS10-A and PS10-B)	GEX	Substantially Equivalent	Beijing Adss Development Co., Ltd.	accessdata.fda.gov
July 17, 2019	K191068	Powersculp laser lipolysis system	PKT	Substantially Equivalent	Wuhan Lotuxs Technology Co., Ltd.	accessdata.fda.gov
October 5, 2016	K161925	CO2 Laser Therapy Machine	GEX	Substantially Equivalent	Beijing Adss Development Co., Ltd.	accessdata.fda.gov
February 9, 2016	K152898	DIODE LASER THERAPY SYSTEMS	GEX	Substantially Equivalent	Beijing Sincoheren Science and Tech. Development Co., Ltd.	accessdata.fda.gov
February 11, 2013	K123435	IPL THERAPY SYSTEM	ONF	Substantially Equivalent	Beijing Sincoheren S&T Development Co, Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 23, 2022. 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.