Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2247224

FEI Number

1000122089

Entity Name

Beaver-Visitec International, Inc

City/State/Country

Little Silver, NJ, US

Establishment Address

39 Sycamore Avenue, Little Silver, NJ 07739, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Beaver-Visitec International, Inc. (Owner Number: 10023467)

Owner / Operator Contact Address

500 Totten Pond Rd, 10 CityPoint, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042918

PMA Number

N/A

All Registered Proprietary Names

E2 Compact Microprobe and Endoscopy System E4 Endoscopy System E2 Microprobe Laser & Endoscopy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYH	Endoscope, Ophthalmic	Gastroenterology, Urology	Class 2	876.1500	2007-11-26
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2007-11-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-11-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Beaver-Visitec International, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012539515	Rio Bravo International Inc	El Paso, TX, US
3012733432	Malosa Medical Instruments (Changshu) Limited	Changshu Jiangsu, CN
3013466775	Grupo American Industries, S.A. de C.V	Ciudad Juarez Chihuahua, MX
3013421458	Beaver-Visitec International, Inc.	Ciudad Juarez Chihuahua, MX
9680620	Beaver-Visitec International, Ltd	BIDFORD-ON-AVON Warwickshire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K834060	F. & F. Koenigkramer	RELIANCE OPHTHALMIC SLIT LAMP R-083	1984-02-04
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2247224. Last updated year: 2026. Please use registration number 2247224 when referencing this establishment in official correspondence.