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

Focus Medical, LLC.: FDA-registered device maker in Bethel, CT, United States, 8 510(k) clearances

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

Focus Medical, LLC. is registered with the FDA (registration 1226486) in Bethel, CT, United States. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 1, 2015. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1226486
FEI number: 3003067608
Address: 23 Francis J. Clarke Circle, Bethel, CT, United States, 06801
Owner or operator: FOCUS MEDICAL, LLC. (9041937)
Roles: Manufacturer, Specification developer
First device listed: June 21, 2000
Registered through: 2027
Brand names listed: Carbon Wave Patch, LPY, LT 100-A, LT100, LT100A, MiniDerm, NaturaLase, NaturaLase 1064 and more

Devices it lists

Device	Product code	Class	Role	Source
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Manufacturer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Manufacturer	accessdata.fda.gov
Laser Assisted Lipolysis	ORK	2	Manufacturer, Specification developer	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer, Specification developer	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Manufacturer	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
September 1, 2015	K151473	NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module	GEX	Substantially Equivalent	Focus Medical, LLC	accessdata.fda.gov
April 12, 2012	K110333	NATURALASE CO2 LASER SYSTEM	ONG	Substantially Equivalent	Focus Medical, LLC	accessdata.fda.gov
August 18, 2010	K101152	NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810	GEX	Substantially Equivalent	Focus Medical, LLC	accessdata.fda.gov
September 7, 2004	K041829	FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS	GEX	Substantially Equivalent	Focus Medical, LLC	accessdata.fda.gov
January 23, 2004	K032667	FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)	GEX	Substantially Equivalent	Focus Medical, LLC	accessdata.fda.gov
July 17, 2003	K031828	NATURALASE LP ND:YAG LASER	GEN	Substantially Equivalent	Focus Medical, LLC	accessdata.fda.gov
April 24, 2000	K992597	LORAD LT-100 LASER TREATMENT SYSTEM	GEX	Substantially Equivalent	Focus Medical, LLC	accessdata.fda.gov
January 16, 1998	K974460	LITE TOUCH ERBIUM LASER TREATMENT SYSTEM	GEX	Substantially Equivalent	Lorad Corp.	accessdata.fda.gov

Compare with other makers

Updated September 1, 2015. 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.