Data / Medical devices / United States / Aurora Dermo Corp

Aurora Dermo Corp: FDA-registered device maker in Miami, FL, United States, 6 510(k) clearances

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

Aurora Dermo Corp is registered with the FDA (registration 3039935725) in Miami, FL, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 23, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3039935725
Address: 6303 Waterford District Dr Ste 400, Miami, FL, United States, 33126
Owner or operator: AURORA DERMO CORP (10096096)
Roles: Repackager or relabeler
First device listed: June 24, 2026
Registered through: 2026
Brand names listed: FRACTAL CO2 Laser, LEVAGE FUSION Surgical laser, LUMINA, MATRIX 4D Hair Removal Laser, PRISMA Q-SWITCH LASER, VISUALIS ULTRASOUND

Devices it lists

Device	Product code	Class	Role	Source
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
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Repackager or relabeler	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	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 23, 2026	K261081	Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)	IYN	Substantially Equivalent	Beijing Konted Medical Technology Co.,Ltd	accessdata.fda.gov
June 12, 2025	K250936	Q-Switched Nd:YAG Laser (SHE-LSP101-1)	GEX	Substantially Equivalent	Beijing Sano Laser S&T Development Co.,Ltd	accessdata.fda.gov
April 4, 2025	K250656	Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)	GEX	Substantially Equivalent	Wuhan Pioon Technology Co., Ltd.	accessdata.fda.gov
January 27, 2025	K242941	CO2 Laser Therapy Systems (SHE-LSP003-1)	GEX	Substantially Equivalent	Beijing Sano Laser S&T Development Co.,Ltd	accessdata.fda.gov
August 21, 2024	K240314	MULA (K2-A1)	ONF	Substantially Equivalent	Guangzhou Ciellulu Photoelectric Technology Co., Ltd.	accessdata.fda.gov
April 6, 2020	K191970	Diode Laser Hair Removal System	GEX	Substantially Equivalent	Beijing Sano Laser S&T Development Co.,Ltd	accessdata.fda.gov

Compare with other makers

Updated July 23, 2026. 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.