Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681134

FEI Number

3000253133

Entity Name

LAP GMBH LASER APPLIKATIONEN

City/State/Country

LUENEBURG Lower Saxony, DE

Establishment Address

ZEPPELINSTRASSE 23, LUENEBURG Lower Saxony D-21337, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LAP of America Laser Applications LLC (Owner Number: 9019434)

Owner / Operator Contact Address

161 Commerce Rd., Ste. 3, Boynton Beach, FL 33426, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232031

PMA Number

N/A

All Registered Proprietary Names

DORADOnova MR3T APOLLO MR3T EASY SLAB EASY CUBE AQUARIUS CARINAiso DORADOnova 3 DORADO 3 DORADO 1 DORADOnova 5 ASTOR CARINAsim CARINAnav APOLLO ARGO NAVIS DORADOnova 1 LUNA 3D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2018-12-19
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2012-11-21
IWE	Monitor, Patient Position, Light-Beam	Radiology	Class 1	892.5780	2008-05-12
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-06-18

Official Correspondent

No official correspondent registered.

US Agent Details

Trent van Arkel Business: LAP of America Laser Applications LLC Email: t.vanarkel@lap-laser.com Phone: (561) 4169250

Related Public Records

Same Entity

LAP of America Laser Applications LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1055485	LAP of America Laser Applications, LLC.	Boynton Beach, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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3030077501	CHABNER XRT, LLC	Port Chester, NY, US
3007791541	Varian Medical Systems China Co., Ltd.	Beijing, CN
1932738	MEDTEC LLC	Orange City, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681134. Last updated year: 2026. Please use registration number 9681134 when referencing this establishment in official correspondence.