(72 days)
No
The summary describes a laser and IPL system for dermatological treatments. There is no mention of AI or ML in the intended use, device description, or any of the other sections provided. The device appears to be a traditional energy-based system.
Yes
The device is indicated for various medical conditions, including tattoo removal, removal of pigmented lesions, hair removal, photocoagulation of dermatological vascular lesions, treatment of facial and leg veins, and treatment of inflammatory acne. These are treatments for health-related conditions, making it a therapeutic device.
No
The device description and indications for use clearly state that the system is intended for treatment procedures such as tattoo removal, pigmented lesion removal, hair removal, and treatment of vascular lesions and acne. There is no mention of the device being used to diagnose conditions or diseases.
No
The device description clearly states it includes laser sources and an IPL handpiece, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Q-Plus T + IPL Laser System is a therapeutic device that uses lasers and intense pulsed light to directly treat conditions on the body, such as tattoo removal, pigmented lesion removal, hair removal, and treatment of vascular lesions and acne. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes direct treatment of the patient's skin and soft tissue.
- Device Description: The description details the laser and IPL sources and their application to the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes based on sample analysis, or any of the typical components or processes associated with IVD devices.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Q-Plus T + IPL laser system is a laser surgical instrument for use in general surgery and dermatology intended for the incision, ablation, and vaporization of soft tissue and for the treatment of vascular and pigmented lesions, tattoo removal, and inflammatory acne (acne vulgaris).
Nd:YAG laser (1064nm) Nd:YAG laser (532nm)
These wavelengths are absorbed by natural chromophores, like melanin, hemoglobin and water and by exogen pigments like tattoo ink. They are indicated for: Tattoo removal: 1064nm: suggested for dark blue and black ink 532nm: suggested for red, orange, yellow, and purple ink Pigmented lesion removal (benign): Café au lait spot Ephalides, solar lentigo (lentigines) Becker Nevus Ota Nevus Nevus spilus
Ruby laser (694nm)
This wavelength is absorbed by natural chromophores, like melanin, hemoglobin and water and by exogen pigments like tattoo ink. It is indicated for: Tattoo removal: Suggested for blue, sky blue, black, green and violet ink Pigmented lesion removal (benign): Café au lait spot Ephalides, solar lentigo (lentigines) Becker Nevus Ota and Ito Nevus Nevus spilus Mongolian spot
IPL 650-1200nm IPL 625-1200nm
Indicated for hair removal
IPL 590-1200m IPL 550-1200nm IPL 570-1200nm
Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions
IPL 550-1200nm
Indicated for face vascular lesions and solar lentigines (benign pigmented lesions)
IPL 400-1200nm
Indicated for inflammatory acne (acne vulgaris)
Product codes
GEX
Device Description
The Q-Plus T + IPL Laser System is intended for the incision, ablation and vaporization of soft tissue for general dermatology. The device includes a Q-Switched Nd:YAG laser source with a max energy of 1000mJ at 1064nm and a max energy of 500mJ at 532nm, a Q-Switched Ruby laser source with a max energy of 1000mJ at 694nm, and an intense pulse light (IPL) hand piece. The Q-Switched lasers are intended for treatment of pigmented lesions and tattoo removal. The optical delivery system for the three laser wavelengths is an articulated arm with replaceable hand pieces with 2, 3, 4, and 6 mm spot sizes. The IPL hand piece, depending on the particular wavelength filter used, is intended for hair removal, treatment of dermatological vascular lesions, benign pigmented lesions and inflammatory acne (acne vulgaris). The IPL hand pieces are provided in a fixed or a replaceable configuration.
The Q-Plus T + IPL laser system incorporates several safety features, including a remote interlock, a key switch and an emergency stop button.
The Q-Plus T + IPL laser system includes a power supply, a cooling system, an optical delivery system, a microprocessor based controller, and safety features that are all either similar or identical to those in the Ultrawave III EX 1320 and Q-Plus T devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Quanta System SPA - Traditional 510(k) - Q-Plus T + IPL Laser System Section 7: 510(k) Summary
Section 7: 510(k) Summary
C25 2 0 2012
Introduction:
This document contains the 510(k) Summary for the Q-Plus T +IPL laser system. The content of this summary is based on the requirements of 21 CFR 807.92(c).
Applicant / Manufacturer Name and Address:
510(k) Contact Person:
Quanta System SPA Via IV Novembre, 116 Solbiate Olona (VA) Italy, 21058
October 5, 2012
21 CFR 878.4810
Class II
GEX
Maurizio Bianchi Requlatory Affairs Manager Quanta System SPA
Q-Plus T + IPL Laser System
Email: Maurizio.bianchi@quantasystem.com Phone: +39-0331-376797 Fax: +39-0331-367815
Laser surgical instrument for use in general .
and plastic surgery and in dermatology
Date Prepared:
Device Name:
Classification:
Classification Name:
Regulation Number
Product Code:
Predicate Devices:
The Q-Plus T + IPL Laser System is claimed to be substantially equivalent to the following legally marketed predicate devices:
- K073549 Q-Plus T manufactured by Quanta System SPA
- K083207 Ultrawave III EX 1320 manufactured by Quanta System SPA
Performance Standards:
There are no mandatory performance standards for this device.
General Device Description:
The Q-Plus T + IPL Laser System is intended for the incision, ablation and vaporization of soft tissue for general dermatology. The device includes a Q-Switched Nd:YAG laser source with a max energy of 1000mJ at 1064nm and a max energy of 500mJ at 532nm, a Q-Switched Ruby laser source with a max energy of 1000mJ at 694nm, and an intense pulse light (IPL) hand The Q-Switched lasers are intended for treatment of pigmented lesions and tattoo piece. removal. The optical delivery system for the three laser wavelengths is an articulated arm with replaceable hand pieces with 2, 3, 4, and 6 mm spot sizes. The IPL hand piece, depending on the particular wavelength filter used, is intended for hair removal, treatment of dermatological vascular lesions, benign pigmented lesions and inflammatory acne (acne vulgaris). The IPL hand pieces are provided in a fixed or a replaceable configuration.
1
Quanta System SPA – Traditional 510(k) – Q-Plus T + IPL Laser System Section 7: 510(k) Summary
The Q-Plus T + IPL laser system incorporates several safety features, including a remote interlock, a key switch and an emergency stop button.
Indications for Use:
| Source selection
| and wavelength | Indications for Use |
|---|---|
| Nd:YAG laser | |
| (1064nm) | |
| Nd:YAG laser | |
| (532nm) | These wavelengths are absorbed by natural chromophores, like melanin, hemoglobin and water and by exogen pigments like tattoo ink. They are indicated for: |
| Tattoo removal: | |
| 1064nm: suggested for dark blue and black ink | |
| 532nm: suggested for red, orange, yellow, and purple ink | |
| Pigmented lesion removal (benign): | |
| Café au lait spot | |
| Ephalides, solar lentigo (lentigines) | |
| Becker Nevus | |
| Ota Nevus | |
| Nevus spilus | |
| Ruby laser | |
| (694nm) | This wavelength is absorbed by natural chromophores, like melanin, hemoglobin and water and by exogen pigments like tattoo ink. It is indicated for: |
| Tattoo removal: | |
| Suggested for blue, sky blue, black, green and violet ink | |
| Pigmented lesion removal (benign): | |
| Café au lait spot | |
| Ephalides, solar lentigo (lentigines) | |
| Becker Nevus | |
| Ota and Ito Nevus | |
| Nevus spilus | |
| Mongolian spot | |
| IPL 650-1200nm | |
| IPL 625-1200nm | Indicated for hair removal |
| IPL 590-1200m | |
| IPL 550-1200nm | |
| IPL 570-1200nm | Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions |
| IPL 550-1200nm | Indicated for face vascular lesions and solar lentigines (benign pigmented lesions) |
| IPL 400-1200nm | Indicated for inflammatory acne (acne vulgaris) |
Comparison of Technological Characteristics:
The Q-Plus T + IPL Laser System has substantially equivalent technological characteristics to the The ten subsystems in the Q-Plus T + IPL laser system contain all nine predicate devices. subsystems of the Q-Plus T (K073549) with the addition of the IPL hand piece subsystem that is cleared with the Ultrawave III EX 1320 (K083207).
The Q-Switched Nd:YAG laser source with a max energy of 1000mJ at 1064nm and a max energy of 500mJ at 532nm is identical to the Q-Switched Nd:YAG laser source utilized in the Q-Plus T device. Also, the Q-Switched Ruby laser source with a max energy of 1000mJ at 694nm is identical the Q-Switched Ruby laser source utilized in the Q-Plus T device. The optical delivery system for the three laser wavelengths is an articulated arm that is also used in the Q-Plus T device. The IPL hand piece portion of the Q-Plus T + IPL Laser System is the same as the IPL hand piece portion of the Ultrawave III EX 1320. In addition, the Q-Plus T + IPL laser system includes a power supply, a cooling system, an optical delivery system, a microprocessor based
2
Quanta System SPA - Traditional 510(k) - Q-Plus T + IPL Laser System Section 7: 510(k) Summary
controller, and safety features that are all either similar or identical to those in the Ultrawave III EX 1320 and Q-Plus T devices.
The laser specifications for the Q-Plus T + IPL laser system are substantially equivalent to the laser specifications for its identified predicate device with respect to the laser source, wavelengths, maximum energy, spot size, fluence, pulse width, repetition rate, beam delivery, power monitor, actuator, and aiming beam.
Comparison of Intended Use:
The Q-Plus T + IPL laser system is a laser surgical instrument for use in general surgery and dermatology intended for the incision, ablation, and vaporization of soft tissue and for the treatment of vascular and pigmented lesions, tattoo removal, and inflammatory acne (acne vulgaris).
The intended use of the laser portion of the Q-Plus T + IPL laser system is the same as the intended use of the previously cleared Q-Plus T as no changes have been made with regard to performance or technology to the Q-Plus T. Furthermore, no changes have been made to the IPL hand piece portion of the subject device since its initial clearance in K051113 and its clearance for use with the Ultrawave III EX 1320 in K083207. Therefore, the intended use of the IPL hand piece used with the Q-Plus T + IPL laser system is substantially equivalent to the intended use of the IPL hand piece used with the Ultrawave III EX 1320.
Substantial Equivalence:
The Quanta System Q-Plus T + IPL laser system is as safe and effective as the predicate devices. The Q-Plus T + IPL laser system has the same intended use and similar technological characteristics and principles of operation as its predicate devices. The minor technological differences between the Q-Plus T + IPL laser system and its predicate devices raise no new issues of substantial equivalence or safety and effectiveness. Thus, the Q-Plus T + IPL laser system is substantially equivalent to its identified predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, black and white design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
Letter dated: December 20, 2012
Quanta System Spa % Mr. Maurizio Bianchi Regulatory Affairs Manager Via IV Novembre, 116 Solbiate Olona, VA Italy 21058
Re: K123168
Trade/Device Name: Q-Plus T + IPL Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II Product Code: GEX Dated: October 05, 2012 Received: October 09, 2012
Dear Mr. Bianchi:
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. Maurizio Bianchi
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/ucm1.1.5809.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,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K 123 68 510(k) Number (if known):
Device Name: Q-Plus T + IPL Laser System
Indications for Use:
| Source selection
| and wavelength | Indications for Use |
|---|---|
| Nd:YAG laser | |
| (1064nm) | |
| Nd:YAG laser | |
| (532nm) | These wavelengths are absorbed by natural chromophores, like melanin, hemoglobin and water and by exogen pigments like tattoo ink. They are indicated for: |
| Tattoo removal: | |
| 1064nm: suggested for dark blue and black ink | |
| 532nm: suggested for red, orange, yellow, and purple ink | |
| Pigmented lesion removal (benign): | |
| Café au lait spot | |
| Ephalides, solar lentigo (lentigines) | |
| Becker Nevus | |
| Ota Nevus | |
| Nevus spilus | |
| Ruby laser | |
| (694nm) | This wavelength is absorbed by natural chromophores, like melanin, hemoglobin and water and by exogen pigments like tattoo ink. It is indicated for: |
| Tattoo removal: | |
| Suggested for blue, sky blue, black, green and violet ink | |
| Pigmented lesion removal (benign): | |
| Café au lait spot | |
| Ephalides, solar lentigo (lentigines) | |
| Becker Nevus | |
| Ota and Ito Nevus | |
| Nevus spilus | |
| Mongolian spot | |
| IPL 650-1200nm | |
| IPL 625-1200nm | Indicated for hair removal |
| IPL 590-1200m | |
| IPL 550-1200nm | |
| IPL 570-1200nm | Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions |
| IPL 550-1200nm | Indicated for face vascular lesions and solar lentigines (benign pigmented lesions) |
| IPL 400-1200nm | Indicated for inflammatory acne (acne vulgaris) |
Prescription Use_ X AND/OR Over-the Counter Use _ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden 2012.12.19 11:23:24 -05'00'
ITIES OF DEFENSE EXAMINATION (ODE)
(Division Sign-Off) Division of Surgical D 510(k) Number_
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