Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012582478

FEI Number

3012582478

Entity Name

ALESI SURGICAL LTD

City/State/Country

Cardiff, GB

Establishment Address

Cardiff Medicentre, Heath Park, Cardiff CF144UJ, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Alesi Surgical Ltd (Owner Number: 10054476)

Owner / Operator Contact Address

Cardiff Medicentre, Heath Park, Cardiff, GB-CRF CF144UJ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN150022

PMA Number

N/A

All Registered Proprietary Names

Ultravision Visual Field Clearing System Ultravision2 Integrated Monopolar L-Hook (H/S) Ultravision Visual Field Clearing System Ultravision Ultravision2 IonPencil Ultravision2 System ULTRAVISION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQM	Surgical Smoke Precipitator	General, Plastic Surgery	Class 2	878.5050	2018-11-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-12-11
PQM	Surgical Smoke Precipitator	General, Plastic Surgery	Class 2	878.5050	2023-12-11
PQM	Surgical Smoke Precipitator	General, Plastic Surgery	Class 2	878.5050	2022-02-23
PQM	Surgical Smoke Precipitator	General, Plastic Surgery	Class 2	878.5050	2017-06-12
PQM	Surgical Smoke Precipitator	General, Plastic Surgery	Class 2	878.5050	2024-08-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-19
PQM	Surgical Smoke Precipitator	General, Plastic Surgery	Class 2	878.5050	2023-12-11
PQM	Surgical Smoke Precipitator	General, Plastic Surgery	Class 2	878.5050	2017-03-23

Official Correspondent

Pravin Patel

US Agent Details

Michele Lucey Business: Lakeshore Medical Device Consulting, LLC Email: lucey_m@msn.com Phone: (603) 7633455

Related Public Records

Same Entity

Alesi Surgical Ltd

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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
3008559295	RIVERSIDE MEDICAL PACKAGING COMPANY LTD	Derby Derbyshire, GB
3004530184	ANDERSEN CALEDONIA LTD	Bellshill Scotland, GB
3007353760	ENERGIST LIMITED	Swansea, GB
3005064998	RDI INC.	Mount Kisco, NY, US
3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012582478. Last updated year: 2026. Please use registration number 3012582478 when referencing this establishment in official correspondence.