Meditech International Inc

FDA Device Registration & Listing · Toronto Ontario, CA · Registration 3003082988

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003082988
FEI Number
3003082988
Entity Name
Meditech International Inc
City/State/Country
Toronto Ontario, CA
Establishment Address
411 Horner Ave Unit 1, Toronto Ontario M8W 4W3, CA
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Meditech International Inc (Owner Number: 9053578)
Owner / Operator Contact Address
411 Horner Ave Unit 1, --, Etobicoke, CA-ON M8W 4W3, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K051875
PMA Number
N/A

All Registered Proprietary Names

BIOFLEX LD-R 100 Treatment Head BIOFLEX MiniPort Professional BIOFLEX Therapist System BIOFLEX DualPort System BIOFLEX Personal System BIOFLEX MultiPort System BIOFLEX MiniPort Home BIOFLEX Arthritis System BIOFLEX LD-I 75 and LD-I 200 Treatment Heads BIOFLEX Shockwave System LD-I 75 and LD-I 200 BIOFLEX Prescription Unit and Related Treatment Heads

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2010-12-09
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2017-10-13
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2008-03-27
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2026-01-09
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2010-12-09
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2008-03-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-03-27

Official Correspondent

No official correspondent registered.

US Agent Details

Mukesh Kumar Business: Brij Strategic Consultations, LLC Email: mkumar@FDAMap.com Phone: (240) 7504893

Related Public Records

Same Entity

Meditech International Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

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, PA***SLT Fiber Delivery System***Sterile***Non-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 3003082988. Last updated year: 2026. Please use registration number 3003082988 when referencing this establishment in official correspondence.
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