Search Results
Found 3 results
510(k) Data Aggregation
K Number
K100053Device Name
MATTIOLI PULSE TWO/THREE PLUS FAMILY
Manufacturer
MATTIOLI ENGINEERING CORP.
Date Cleared
2010-03-10
(61 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MATTIOLI ENGINEERING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MATTIOLI PULSE TWO/THREE PLUS is an Intense Pulse Light (IPL) device family indicated for use in aesthetic applications (based on selective photothermolysis) , in the treatment of various benign pigmented lesions and hair removal and that produce different effects depending on the applicator that is used:
SA APPLICATOR:
Model SN: Wavelengths from 560 - 1200 nm are indicated for treatment of benign pigmente (epidermal and coutaneous) lesions, including hyperpigmentation, warts, lentigines, nevi, melasma, and cafe-au-lait.
VA APPLICATOR
Model VN: Wavelengths from 510 - 1200 nm are indicated for the treatment of benign vascular lessons including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider anglormas, polkiloderma of civatte; leg veins, facial veins and venous malformations.
HR APPLICATORS indicated for the treatment of unwanted hair (i.e. hair removal). Model HN: Wavelengths from 650-1200 nm for skin types I-IV; Model HF: Wavelengths from 710 - 1200 nm for skin type V
The equipment should only be used under medical supervision.
Device Description
The MATTIOLI PULSE TWO/THREE Plus Family is an Intense Pulse Light (IPL) generator device producing on the skin different effects depending on the applicator used by the operator:
SR Applicator: its purpose is to stimulate the regenerative process of the skin. It uses the principle of the selective absorption of the different light wavelengths, without damaging the skin structure.
HR Applicator: its purpose is to destroy thermally the hair bulb, due to the absorption of a selected range of radiated wavelength. The selective absorption of different wavelengths is either used by HR to obtain the desired effect without damaging the surrounding skin structures.
VR Applicator: Its purpose is to treat benign pigmented (epidermal and cutaneous) lesions including warts scars abnd striae. It is also intended for treatment of benign (cutaneous) vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangectasias, rosacea, melasmna, angiomas and spider angiomas, polkiloderma of civatte; leg veis, facial veins and venous malformations.
The two systems differ substantially only by the case: it is "desktop" style for MATTIOLI PULSE TWO PLUS device and a standard case, with wheels to allow easy movement on the floor, for PULSE THREE PLUS device.
Both equipments consist of a console, containing the electronic supply system for capacitor bank charge , the computerized control system (CCS) , and one or two hand pieces in which are contained the light generators devices (flash lamp) and the necessary filtered light guide for the selection of the wavelengths range.
The computerized control system (CCS) monitors and controls either the equipment and interfaces with the operator, through an 8.2" colour back lighted LCD screen display and a touch screen panel, displaying all the selected parameters and indications on the status of the machine. The selection of each command and parameter simply occurs by touching the LCD screen.
Each applicator is composed basically by the flash-lamp, a water cooled reflector, a filtered light guide, a light guide cooler, a flash-counter and the pushbutton for the activation of flash emission.
Ask a Question
K Number
K042590Device Name
TRANSDERM IONTO SYSTEM, MK 2
Manufacturer
MATTIOLI ENGINEERING CORP.
Date Cleared
2004-10-14
(21 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
MATTIOLI ENGINEERING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TRANSDERM IONTO System MK 2 is a powered iontophoresis drug delivery system that is for medical purposes and can be used as an alternative to injections. For the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
Device Description
The TRANSDERM IONTO System MK 2 consists of a probe, power supply/support, and a disposable drug delivery cap electrode. The TRANSDERM IONTO System MK 2 generates mechanical vibrations that are produced by an electric motor which has an unbalanced weight applied on the device shaft. The vibrations are transmitted by the motor body to a plastic plate that is held in contact with the skin through the disposable drug delivery cap electrode. Electrical pulses are produced by an electronic pulse generator that is able to generate bursts of pulses that are applied to the skin through electrodes applied to a plastic plate (the applicator). The design of the device provides one channel output. The TRANSDERM IONTO System MK 2 requires a DC supply of 9 V, 1.0 A max. This power source is supplied by, the TRANS-BASE module which is connected to mains through a removable supply cord and is equipped with a proper connector receptacle to fit the connector male mounted on TRANSDERM IONTO probe supply cable. The TRANS-BASE is equipped with a 15 w AC-DC switch mode power module. The drug delivery cap electrode is adhered to the patient's skin and then saturated The urug delivery cap electrug delivery cap electrode is affixed to the while solution: "Oneo the artig changes": applicator head can be attached pation internal side of the drug delivery cap electrode.
Ask a Question
K Number
K032968Device Name
TRSANSDERM IONTO SYSTEM
Manufacturer
MATTIOLI ENGINEERING CORP.
Date Cleared
2003-12-02
(70 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
MATTIOLI ENGINEERING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TRANSDERM IONTO System is a powered iontophoresis drug delivery system that is indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
Device Description
The TRANSDERM IONTO System consists of a probe, power supply/support, and a disposable drug delivery cap clectrode. Flectrical pulses are produced by an electronic pulse generator that is able to generate bursts of pulses that are applied to the skin through electrodes applied to a plastic plate (the applicator). The design of the device provides one channel output. The TRANSDERM IONTO System requires a DC supply of 9 V, 1.0 A max. This power source is supplied by, the TRANS-BASE module which is connected to mains through a removable supply cord and is equipped with a proper connector receptacle to fit the connector malc mounted on TRANSDERM IONTO probe supply cable. The TRANS-BASE is equipped with a 15 w AC-DC switch mode power module. The drug delivery cap electrode is adhered to the patient's skin and then saturated with ionic solution. Once the drug delivery cap electrode is affixed to the patient's skin, the TRANSDERM IONTO probe's applicator head can be attached to the internal side of the drug delivery cap electrode.
Ask a Question
Page 1 of 1