(85 days)
The device is intended to be used in surgical, aesthetic applications in the medical specialties of general and plastic surgery and dermatology, including:
-
Treatment of benign vascular lesions
-
Hair removal
-
Permanent* hair reduction
- permanent hair reduction defined as reduced hair growth without maintenance when measured at 6, 9 and 12 months.
The laser device Echo is a 160 W diode laser emitting at 808 nm laser wavelength. The device is a therapeutic and aesthetic medical laser system for professional use only.
For the release of laser radiation to the patient, the device uses, as delivery system, a fiber with a handpiece plugged on its end.
Echo is a transportable mobile electrical equipment with a graphical user interface (GUI) for user-device interaction.
Laser radiation is delivered through optical fibers connected to handpieces having fix spot dimension.
The device is equipped with an integrated skin cooler. In this case, a specific housing called Skin Cooler handpiece is provided to provide skin cooling and housing the laser handpiece at the same time.
Laser emission can be activated by the footswitch or by a finger-switch placed on Skin Cooler handpieces.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample size, ground truth establishment, or multi-reader multi-case studies. The document is an FDA 510(k) clearance letter and summary for a laser device, primarily focusing on its equivalence to predicate devices based on technical specifications and non-clinical testing for safety and effectiveness according to established standards. It does not include the detailed clinical study information you requested.
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October 20, 2023
Quanta System Spa Dario Bandiera Regulatory Affairs Manager Via Acquedotto, 109 Samarate, VA 21017 Italy
Re: K232236
Trade/Device Name: Echo Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: July 26, 2023 Received: July 27, 2023
Dear Dario Bandiera:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232236
Device Name Echo
Indications for Use (Describe)
The device is intended to be used in surgical, aesthetic applications in the medical specialties of general and plastic surgery and dermatology, including:
-
Treatment of benign vascular lesions
-
Hair removal
-
Permanent* hair reduction
- permanent hair reduction defined as reduced hair growth without maintenance when measured at 6, 9 and 12 months.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| 510(K)# | 232236 | |
|---|---|---|
| Applicant /Manufacturerand address: | Quanta System S.p.A., Via Acquedotto 109, 21017Samarate (VA), Italy | |
| Contact person: | Dario BandieraRA ManagerQuanta System S.p.A.Email: dario.bandiera@quantasystem.comPhone: +39-0331-376797 | |
| Date Prepared: | 10/02/2023 | |
| Trade/device name: | Echo | |
| Classification: | Class II | |
| Classification Name: | Laser surgical instrument for use in general andplastic surgery and in dermatology. | |
| Regulation Number: | 21 CFR 878.4810 | |
| Product Code: | GEX | |
| Predicate devices: | MeDioStar (K192483) and LightSheer Desire(K170179) |
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Device description 1
The laser device Echo is a 160 W diode laser emitting at 808 nm laser wavelength. The device is a therapeutic and aesthetic medical laser system for professional use only.
For the release of laser radiation to the patient, the device uses, as delivery system, a fiber with a handpiece plugged on its end.
Echo is a transportable mobile electrical equipment with a graphical user interface (GUI) for user-device interaction.
Laser radiation is delivered through optical fibers connected to handpieces having fix spot dimension.
The device is equipped with an integrated skin cooler. In this case, a specific housing called Skin Cooler handpiece is provided to provide skin cooling and housing the laser handpiece at the same time.
Laser emission can be activated by the footswitch or by a finger-switch placed on Skin Cooler handpieces.
Comparison with the predicate 2
In Table 1, the main specifications of the subject device are summarized and compared to the predicates:
| Specification | Subject device | Predicate 1 | Predicate 2 | Comments |
|---|---|---|---|---|
| Device Name | Echo | MeDioStar | Lightsheer Desire | |
| K number | K192483 | K170179 | -- | |
| Manufacturer | Quanta System S.p.A. | Asclepion GmbH | Lumenis | -- |
| Product Code | GEX | GEX | GEX | -- |
| Laser Sources | Diode laser | Diode laser | Diode laser | Same |
| LaserWavelengths | 808 nm +/- 20 nm | 755-950 nm | 805-1060 nm | Whitin the rangeof the predicatedevices |
| Indications foruse | Intended for surgical,aesthetic and cosmeticapplications in themedical specialties ofgeneral and plasticsurgery anddermatology.Intended for thetreatment of benignvascular lesions.Intended for hairremoval and permanenthair reduction. | Intended for surgical, aestheticand cosmetic applications in themedicalspecialties of general andplastic surgery anddermatology.Intended for the treatment ofbenign vascular lesions.Intended for hair removal,permanent hair reduction andthe treatment of benignpigmented lesions. | indicated for use insurgical, aesthetic, andcosmetic applicationsin the medicalspecialties of generaland plastic surgery,and dermatology. TheLightSheerDesireSystem is intended foruse on all skin types(Fitzpatrick skin types I— VI), including tannedskin.The LightSheer DesireSystemwithLightSheer ET/XC805nm LaserHandpieces areintended for:• Treatment of benignvascular lesions,including angiomas,hemangiomas,telangiectasia andother benign vascularlesions and leg veins | Same |
Table 1: Main specifications comparison table.
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| Specification | Subject device | Predicate 1 | Predicate 2 | Comments |
|---|---|---|---|---|
| Device Name | Echo | MeDioStar | Lightsheer Desire | |
| Treatment ofpseudofolliculitisbarbae (PFB)Hair removal,permanent hairreduction* Treatment of benignpigmented lesions | ||||
| Pulse width(max) | 5 - 100 ms | 3 - 400 ms | Up to 400 ms | Whitin the rangeof the predicatedevices |
| Fluence (max) | 5-90 J/cm2 | 210 J/cm²Max. Fluence Hair reduction60 J/cm² | 10-100 J/cm2 | Same as thepredicate device 2 |
| Spot Size | 12, 18, 24 mm (rounddiameter) respectivearea (cm²) 1,13 –2,54 - 4,52 | square 10x10, 15x10, 30x10,31.5x31.5 respective area(cm²) 1 - 1,5 -3 - 9.9 | Square 9x9, 27x9,22x35respective area(cm²) 0.81 - 2.43 -7.7 | Areas within therange of thepredicate devices |
| Repetition Rate(max) | Up to 10 Hz | Up to 20 Hz | Up to 3 Hz | Whitin the rangeof the predicatedevice 1 |
| Skin Cooling | Contact skin cooling | contact skin cooling system(metal probe cooled by a peltierelement) | Chilltip contact cooling | Same as Predicatedevices (contactmode) |
| Power Supply | Single phase,100-240V50-60 Hz | Single phase,100-240V50-60 Hz | Single phase,100-240V50-60 Hz | Same as predicatedevices |
Indication for use 3
The device is Intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology.
Intended for the treatment of benign vascular lesions.
Intended for hair removal and permanent hair reduction*.
- Permanent hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.
Non-clinical tests 4
The present device was subject to non-clinical testing according to the following standards (Table 2):
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Table 2: Applied standards.
| Standard | |
|---|---|
| IEC 60601-1: 2005/AC 1:2006/A1:2012/AC1:2014/AMD2:2020 | Medical electrical equipment -Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-2:2014/A1:2020 | Medical electrical equipment - Part 1-2: General requirementsfor basic safety and essential performance - Collateral Standard: Electromagnetic disturbances |
- Requirements and tests
IEC 60601-1-6: 2010/AMD1: 2013 Collateral standard: Usability
IEC 62366-1: 2015/COR1: 2016 Part 1: Application of usability engineering to medical devices IEC 62304: 2006/AMD1: 2015 Medical device software (SW)
IEC 60601-2-22: 2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1: 2014 Safety of laser products – Part 1: Equipment classification and requirements ISO 10993-1: 2018 Biological evaluation of medical devices
The results of the non-clinical performance standards testing support that the subject device can be used safely and effectively.
Substantial equivalence discussion ട
Echo has the same intended use of the predicate devices and comparable technical specifications.
ട Conclusions
Non-clinical tests conducted support that the device can be used safely and effectively for the proposed indications for use. The differences in technological characteristics between the subject and predicate devices do not raise new questions regarding safety and effectiveness for the proposed indications for use. Thus, the subject device is considered to be substantially equivalent to the predicate devices.
§ 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.