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Blink Bright Medical, Inc.: FDA-registered device maker in Houston, TX, United States, 10 510(k) clearances

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

Blink Bright Medical, Inc. is registered with the FDA (registration 3043047259) in Houston, TX, United States. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 2, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3043047259
Address: 5252 Hollister St Ste 318, Houston, TX, United States, 77040
Owner or operator: Blink Bright Medical, Inc. (10095007)
Roles: Repackager or relabeler
First device listed: January 14, 2026
Registered through: 2026
Brand names listed: Zen1550, Zen980, ZenDiode HR, ZenFX, ZenFX CO2, ZenLight, ZenPL, ZenPico and more

Devices it lists

Device	Product code	Class	Role	Source
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	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
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	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
July 2, 2025	K251031	Fiber Laser Treatment Systems (HS-232,HS-233)	ONG	Substantially Equivalent	Shanghai Apolo Medical Technology Co., Ltd.	accessdata.fda.gov
April 10, 2024	K232409	Electromagnetic Stimulation Systems	NGX	Substantially Equivalent	Shanghai Apolo Medical Technology Co., Ltd.	accessdata.fda.gov
October 13, 2022	K221770	Fiber Laser Treatment System	ONG	Substantially Equivalent	Shanghai Apolo Medical Technology Co., Ltd.	accessdata.fda.gov
January 28, 2022	K203395	Platform treatment system	GEX	Substantially Equivalent	Shanghai Apolo Medical Technology Co., Ltd.	accessdata.fda.gov
July 15, 2020	K201109	CO2 Laser Therapy System	GEX	Substantially Equivalent	Shanghai Apolo Medical Technology Co., Ltd.	accessdata.fda.gov
May 28, 2020	K200116	PicoSecond Nd: YAG Laser System	GEX	Substantially Equivalent	Shanghai Apolo Medical Technology Co., Ltd.	accessdata.fda.gov
May 15, 2020	K200746	IPL Treatment Systems	ONF	Substantially Equivalent	Shanghai Apolo Medical Technology Co., Ltd.	accessdata.fda.gov
April 17, 2020	K200118	Diode Laser Therapy Device	GEX	Substantially Equivalent	Shanghai Apolo Medical Technology Co., Ltd.	accessdata.fda.gov
August 16, 2019	K191349	980nm Diode Laser Therapy Device	GEX	Substantially Equivalent	Shanghai Apolo Medical Technology Co., Ltd.	accessdata.fda.gov
June 17, 2019	K190936	Q-Switched Nd: YAG Laser System	GEX	Substantially Equivalent	Shanghai Apolo Medical Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated July 2, 2025. 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.