Data / Medical devices / United States / Biowound Solutions

Biowound Solutions: FDA-registered device maker in Las Vegas, NV, United States, 8 510(k) clearances

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

Biowound Solutions is registered with the FDA (registration 3034456223) in Las Vegas, NV, United States. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 16, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3034456223
Address: 6823 W Post Rd Ste 102, Las Vegas, NV, United States, 89118
Owner or operator: BioWound Solutions (10093220)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: April 17, 2025
Registered through: 2026
Brand names listed: Actigraft Plus System, EMO Led, Exsalt, Pensar MicroDoc, Ultramist, WoundPro+, bio-ConneKt Wound Matrix

Devices it lists

Device	Product code	Class	Role	Source
Dressing, Wound, Drug	FRO	U	Repackager or relabeler, Specification developer	accessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2	Repackager or relabeler	accessdata.fda.gov
Oximeter, Tissue Saturation	MUD	2	Manufacturer	accessdata.fda.gov
Peripheral Blood Processing Device For Wound Management	PMQ	2	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler	accessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)	KGN	U	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
December 16, 2024	K240809	LUOFUCON® Silver Collagen Dressing	FRO	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.	accessdata.fda.gov
April 2, 2024	K240601	SnapshotNIR model KD205	MUD	Substantially Equivalent	Kent Imaging, Inc.	accessdata.fda.gov
March 12, 2024	K240132	EmoLED (v. 2-USA)	GEX	Substantially Equivalent	Emoled, Srl	accessdata.fda.gov
October 23, 2020	K200223	PocketDoc Micro Wound Therapy System	OMP	Substantially Equivalent	Pensar Medical, LLC	accessdata.fda.gov
December 1, 2016	K150960	WoundPro Negative Pressure Wound Therapy System	OMP	Substantially Equivalent	Pensar Medical, LLC	accessdata.fda.gov
July 22, 2014	K140456	BIO-CONNEKT WOUND MATRIX	KGN	Substantially Equivalent	MLM Biologics, Inc.	accessdata.fda.gov
October 12, 2010	K100580	EXSALT WOUND DRESSING	FRO	Substantially Equivalent	Exciton Technologies, Inc.	accessdata.fda.gov
February 11, 2009	K080949	KERATEC WOUND DRESSINGS	FRO	Substantially Equivalent	Keratec Limited	accessdata.fda.gov

Compare with other makers

Updated December 16, 2024. 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.