Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037966040

FEI Number

3037966040

Entity Name

Infinity Medical International LLC

City/State/Country

Miami, FL, US

Establishment Address

245 Se 1st St Ste 214, Miami, FL 33131, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

infinity medical (Owner Number: 10093099)

Owner / Operator Contact Address

245 se 1st street, 214, Miami, FL 33131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDF1RST RIGID CYSTOSCOPE: MF027190CP MF04302C MF1227190CP MF124302C MF3027190CP MF304302C MF7027190CP MF704302C Thulium laser 60w Medf1rst needle holder SEMI RIGID URETEROSCOPE MEDF1RST: MF430.4.5.1C MF430.6.1C MF430.6.2C MF430.8.1C MF430.8.2C Medf1rst laparoscopic instruments Hybrid medf1rst resectoscope and accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-03-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-03-25
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2026-03-02
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-03-03
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-03-02
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2026-03-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

infinity medical

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, 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

Similar Registrations

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3008386005	IAN JAMIESON PTY LTD	Fyshwick Australian Capital Territory, AU
3008837339	STRYKER EMEA Supply Chain Services	Venlo Limburg, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037966040. Last updated year: 2026. Please use registration number 3037966040 when referencing this establishment in official correspondence.