(72 days)
| Source selectionand 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 ink532nm: suggested for red, orange, yellow, and purple inkPigmented lesion removal (benign):Café au lait spotEphalides, solar lentigo (lentigines)Becker NevusOta NevusNevus 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 inkPigmented lesion removal (benign):Café au lait spotEphalides, solar lentigo (lentigines)Becker NevusOta and Ito NevusNevus spilusMongolian spot |
| IPL 650-1200nmIPL 625-1200nm | Indicated for hair removal |
| IPL 590-1200mIPL 550-1200nmIPL 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) |
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 Quanta System SPA Q-Plus T + IPL Laser System is a laser surgical instrument designed for use in general and plastic surgery and in dermatology. It's intended for the incision, ablation, and vaporization of soft tissue, as well as for the treatment of vascular and pigmented lesions, tattoo removal, and inflammatory acne (acne vulgaris).
The device's performance is demonstrated through substantial equivalence to two predicate devices: K073549 Q-Plus T and K083207 Ultrawave III EX 1320. The submission states that "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."
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission based on technological characteristics and intended use, formal "acceptance criteria" with specific performance metrics (like sensitivity, specificity, or accuracy) derived from a clinical study are not provided in the document. Instead, the "acceptance criteria" can be inferred as demonstrating that the technological characteristics and indications for use of the Q-Plus T + IPL Laser System are substantially equivalent to the cleared predicate devices.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Laser Source: Nd:YAG (1064nm & 532nm) and Ruby (694nm) performance substantially equivalent to K073549 (Q-Plus T). | The Q-Switched Nd:YAG laser source and Q-Switched Ruby laser source are identical to those utilized in the Q-Plus T device. |
| IPL Hand Piece: Performance substantially equivalent to K083207 (Ultrawave III EX 1320). | The IPL hand piece portion is the same as the IPL hand piece portion of the Ultrawave III EX 1320. |
| Optical Delivery System: Substantially equivalent to predicate devices. | The optical delivery system for the three laser wavelengths (articulated arm) is also used in the Q-Plus T device. |
| Other Components: (Power supply, cooling system, microprocessor controller, safety features) substantially equivalent to predicate devices. | These components are "either similar or identical to those in the Ultrawave III EX 1320 and Q-Plus T devices." |
| Laser Specifications: (wavelengths, max energy, spot size, fluence, pulse width, repetition rate, beam delivery, power monitor, actuator, aiming beam) substantially equivalent to predicate devices. | Laser specifications are "substantially equivalent" to the identified predicate device (Q-Plus T) with respect to these parameters. |
| Intended Use: The intended use of the combined system is substantially equivalent to the intended uses of the predicate devices. | The intended use of the laser portion is the "same as the intended use of the previously cleared Q-Plus T." The intended use of the IPL hand piece is "substantially equivalent to the intended use of the IPL hand piece used with the Ultrawave III EX 1320." |
| Safety and Effectiveness: No new issues of safety and effectiveness compared to predicate devices. | The device is deemed "as safe and effective as the predicate devices." |
Study that Proves the Device Meets Acceptance Criteria:
The current submission for the Q-Plus T + IPL Laser System does not provide details of specific clinical or performance studies with acceptance criteria in the traditional sense (e.g., sensitivity, specificity, or controlled patient trials). Instead, the "study" proving the device meets the acceptance criteria is a benchmarking and comparison study against two legally marketed and cleared predicate devices (K073549 Q-Plus T and K083207 Ultrawave III EX 1320).
The argument for substantial equivalence is based on:
- Identical/Similar Technological Characteristics: The laser sources (Q-Switched Nd:YAG and Ruby) are identical to the Q-Plus T. The IPL hand piece is the same as the IPL hand piece of the Ultrawave III EX 1320. Other components are similar or identical.
- Equivalent Intended Use: The intended uses align with the combined indications of the predicate devices.
This means the "study" is effectively a literature review and technical comparison of the device's specifications and indications for use against those of the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. The submission relies on technical comparison and the established safety and effectiveness of the predicate devices. There is no mention of a separate "test set" of patients or data for this specific submission to prove clinical efficacy.
- Data Provenance: Not applicable for a new clinical test set. The provenance relies on the regulatory clearances and underlying data (which are not detailed here) for the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No new test set requiring expert ground truth establishment for this 510(k) submission.
4. Adjudication Method for the Test Set:
- Not applicable. No new test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is not mentioned or required for this 510(k) submission, which focuses on substantial equivalence to existing devices based on technological characteristics and intended use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser system, not an algorithm, and its performance inherently involves human operation.
7. The Type of Ground Truth Used:
- Indirect Ground Truth: The "ground truth" for the Q-Plus T + IPL Laser System is established indirectly through the proven safety and efficacy of the predicate devices for their respective indications. The FDA's clearance of the predicate devices implies that sufficient evidence (including, for example, clinical data, performance testing, and expert consensus from those prior submissions) was provided to support their safety and effectiveness.
8. The Sample Size for the Training Set:
- Not applicable. As this is not an AI/algorithm device that requires a training set. The submission is based on demonstrating substantial equivalence to pre-existing, cleared devices.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
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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.
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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 selectionand 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 ink532nm: suggested for red, orange, yellow, and purple inkPigmented lesion removal (benign):Café au lait spotEphalides, solar lentigo (lentigines)Becker NevusOta NevusNevus 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 inkPigmented lesion removal (benign):Café au lait spotEphalides, solar lentigo (lentigines)Becker NevusOta and Ito NevusNevus spilusMongolian spot |
| IPL 650-1200nmIPL 625-1200nm | Indicated for hair removal |
| IPL 590-1200mIPL 550-1200nmIPL 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
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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
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Indications for Use
K 123 68 510(k) Number (if known):
Device Name: Q-Plus T + IPL Laser System
Indications for Use:
| Source selectionand 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 ink532nm: suggested for red, orange, yellow, and purple inkPigmented lesion removal (benign):Café au lait spotEphalides, solar lentigo (lentigines)Becker NevusOta NevusNevus 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 inkPigmented lesion removal (benign):Café au lait spotEphalides, solar lentigo (lentigines)Becker NevusOta and Ito NevusNevus spilusMongolian spot |
| IPL 650-1200nmIPL 625-1200nm | Indicated for hair removal |
| IPL 590-1200mIPL 550-1200nmIPL 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_
Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________
Page 23 of 407
§ 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.