(61 days)
Not Found
Not Found
No
The summary describes a standard IPL device with a computerized control system for parameter selection and monitoring, but there is no mention of AI or ML capabilities for image processing, diagnosis, or treatment planning.
Yes
The device is indicated for the "treatment of various benign pigmented lesions and hair removal" and other medical conditions like "port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma," etc., which constitutes a therapeutic use.
No
The device is described as an Intense Pulse Light (IPL) family indicated for aesthetic applications, treating benign pigmented lesions, vascular lesions, and hair removal. Its purpose is to produce therapeutic effects on the skin, not to diagnose conditions.
No
The device description clearly outlines hardware components such as an IPL generator, console, electronic supply system, capacitor bank, hand pieces, flash lamp, filtered light guide, LCD screen, and touch screen panel. While it includes a computerized control system (CCS), it is integrated into a physical device that emits light for treatment.
Based on the provided text, the MATTIOLI PULSE TWO/THREE PLUS device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "aesthetic applications," "treatment of various benign pigmented lesions and hair removal," and "treatment of benign vascular lessons." These are all procedures performed directly on the patient's body.
- Device Description: The description details an "Intense Pulse Light (IPL) generator device producing on the skin different effects." It describes handpieces that contain light generators and filtered light guides for applying light to the skin.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The MATTIOLI PULSE TWO/THREE PLUS does not perform any such analysis of biological specimens.
The device is a therapeutic and aesthetic device that applies light energy directly to the patient's skin for treatment purposes.
N/A
Intended Use / Indications for 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.
Product codes
ONF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical supervision
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: None
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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510(k) Premarket Notification rev 1.0 page 1 of 3
K1000053
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510(k) SUMMARY
| Submitter: | Mattioli Engineering Corporation
MAR 1 0 2010 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Gian Franco Bernabei |
| Date Summary Prepared: | december 11, 2009 |
| Device Trade Name: | Mattioli Pulse Two/Three Plus Family |
| Common Name: | IPL system generator |
| Classification Name: | Powered Light Based Non-Laser Surgical Instrument With
Thermal Effect
ONF
21 CFR 878.4810 |
| Equivalent Device: | Advanced Technology Laser, Co., Ltd.: Angelite Family of
Intense Pulsed Light Systems |
| 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, |
1
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.
The MATTIOLI PULSE TWO/THREE PLUS is an Intense Pulse Light (IPL) device family indicated for use in aesthetic and cosmetic applications (based on selective photothermolysis, in the treatment of acne, various benign pigmented lesions and hair removal and that produce different effects depending on the applicator that is used:
HR APPLICATORS:
Intense Pulse Light Energy Wavelengths from 650 (HN type) or 710 (HF type ) - 960 nm are indicated for the treatment of unwanted hair (i.e., hair removal).
SR APPLICATOR:
Intense Pulse Light Energy Wavelengths from 560 - 960 nm are indicated for skin resurfacing procedure , for the treatment of inflammatory acne and decrease the appearance of dark spots.
VR APPLICATOR
Intended Use:
2
| | Intense Pulse Light Energy Wavelengths from 510 - 960 nm
are indicated for the treatment of benign pigmented
(epidermal and coetaneous) lesions including warts, scars
and striae. For the treatment of benign (cutaneous) vascular
lesions including port wine 'stains, hemangiomas, facial,
truncal and leg telangiectasias, rosacea, melasmna,
angiomas and spider anglormas, polkiloderma of civatte; leg
veins, facial veins and venous malformations. |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Rationale for Substantial
Equivalence: | The product specification, functionality, indication for use,
and treatment parameters of the Mattioli Pulse Two/Three
Plus Family are the same or very similar to the legally
marketed Angelite Family of Intense Pulsed Light Systems. |
| | Both systems have the same indication for use. |
| | Both systems uses a flash lamp, which emitted light is
delivered to the patient via a glass light guide. |
| | The Mattioli Pulse Two/Three Plus Family output
characteristics (including pulse duration and fluence) are
identical, or very similar, to those of the predicate device. |
| | Both systems are microprocessor controlled devices. |
| | Both systems utilize an internal closed loop water-air heath
exchanger circuit for optimal thermal control of system
temperature. |
The risks and benefits for the Mattioli Pulse Two/Three Plus Family are comparable to those for the predicate device. Therefore, the introduction of this IPL device should not raise new questions of Safety and Effectiveness .
Non-Clinical Performance Data: None
Clinical Performance Data:
None
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with outstretched wings, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mattioli Engineering Corporation % Mr. Gian Franco Bernabei 8300 Greensboro Drive, Suite 800 McLean, Virginia 22102
MAR 1 0 2010
Re: K100053
Trade/Device Name: Mattioli Pulse Two/Three Plus Family
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology
Regulatory Class: Class II Product Code: ONF Dated: February 25, 2010 Received: March 01, 2010
Dear Mr. Bernabei:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act ' or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
4
Page 2 - Mr. Gian Franco Bernabei
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
y yours,
for
Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Statement of Indications for Use
510(k) Number (if known): K100053
Device Name: Mattioli Pulse TWO/THREE Plus Family
Indications for 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| Page | of _______ |
| 510(k) Number | K100053 |
|---|---|
| --------------- | --------- |