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Lisa Laser Products GMBH: FDA-registered device maker in KATLENBURG-LINDAU Lower Saxony, Germany, 9 510(k) clearances

Name: Lisa Laser Products GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Lisa Laser Products GMBH is registered with the FDA (registration 3003168101) in KATLENBURG-LINDAU Lower Saxony, Germany. It lists 2 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 19, 2022. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3003168101
Address: Albert-Einstein-Str. 4, KATLENBURG-LINDAU Lower Saxony, Germany, 37191
Owner or operator: OMNIGUIDE, INC. (9070939)
Roles: Manufacturer
First device listed: December 30, 2021
Registered through: 2026
Brand names listed: FelxGuard, Powered laser surgical instrument - RevoLix 120, Powered laser surgical instrument - RevoLix 200, Powered laser surgical instrument - RevoLix Duo, Powered laser surgical instrument - RevoLix Laser, Powered laser surgical instrument - Sphinx Jr., RevoLix and R Jr

Devices it lists

Device	Product code	Class	Role	Source
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	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
May 19, 2022	K211534	RevoLix HTL	GEX	Substantially Equivalent	Lisa Laser Products GmbH	accessdata.fda.gov
March 18, 2014	K132975	SPHINX JR	GEX	Substantially Equivalent	Allmed Systems, Inc.	accessdata.fda.gov
February 19, 2013	K110941	REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200	GEX	Substantially Equivalent	Allmed Systems, Inc.	accessdata.fda.gov
June 21, 2007	K070924	FLEXGUARD	GEX	Substantially Equivalent	Allmed Systems, Inc.	accessdata.fda.gov
April 17, 2007	K070466	REVOLIX DUO LASER SYSTEM	GEX	Substantially Equivalent	Allmed Systems, Inc.	accessdata.fda.gov
March 26, 2007	K070476	REVOLIX 120	GEX	Substantially Equivalent	Allmed Systems, Inc.	accessdata.fda.gov
June 1, 2005	K051167	REVOLIX AND REVOLIX JR	GEX	Substantially Equivalent	Allmed Systems, Inc.	accessdata.fda.gov
January 20, 2004	K033437	SPHINX LASER SYSTEMS	GEX	Substantially Equivalent	Allmed Systems, Inc.	accessdata.fda.gov
January 15, 2004	K033423	REVOLIX LASER SYSTEMS	GEX	Substantially Equivalent	Allmed Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 19, 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.