Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1055485

FEI Number

1000113153

Entity Name

LAP of America Laser Applications, LLC.

City/State/Country

Boynton Beach, FL, US

Establishment Address

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

Establishment Type(s)

Repack or Relabel 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

K173926

PMA Number

N/A

All Registered Proprietary Names

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

Registered Product Listings

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

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
9681134	LAP GMBH LASER APPLIKATIONEN	LUENEBURG Lower Saxony, DE

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

Similar Registrations

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1225473	AADCO MEDICAL, INC.	RANDOLPH, VT, US
3003768277	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3007615597	INNOKAS MEDICAL OY	KEMPELE Pohjois-Pohjanmaa, FI
3017956012	SHENZHEN TENGFEI YU TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN
2436865	AKTINA MEDICAL CORP.	Congers, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1055485. Last updated year: 2026. Please use registration number 1055485 when referencing this establishment in official correspondence.