(85 days)
No
The summary describes a laser device with standard components and functionalities, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The 'Device Description' explicitly states, "The device is a therapeutic and aesthetic medical laser system for professional use only."
No
The device description clearly states it is a "therapeutic and aesthetic medical laser system" used for treatments like vascular lesion removal and hair reduction, not for diagnosing conditions.
No
The device description clearly details hardware components such as a laser, fiber, handpiece, footswitch, finger-switch, and an integrated skin cooler, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical and aesthetic applications, specifically treating vascular lesions and hair removal/reduction. These are therapeutic and cosmetic procedures performed directly on the patient's body.
- Device Description: The description details a laser device that emits radiation for treatment. It describes a delivery system (fiber and handpiece) and features like a skin cooler. This aligns with a device used for external treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to analyze samples from the body to provide diagnostic information. This device is used to directly treat the body.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
Device Description
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.
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)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.
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.
1
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.
2
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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4
510(k) Summary
| 510(K)# | 232236 | |
|---|---|---|
| Applicant / | ||
| Manufacturer | ||
| and address: | Quanta System S.p.A., Via Acquedotto 109, 21017 | |
| Samarate (VA), Italy | ||
| Contact person: | Dario Bandiera | |
| RA Manager | ||
| Quanta System S.p.A. | ||
| Email: dario.bandiera@quantasystem.com | ||
| Phone: +39-0331-376797 | ||
| Date Prepared: | 10/02/2023 | |
| Trade/device name: | Echo | |
| Classification: | Class II | |
| Classification Name: | Laser surgical instrument for use in general and | |
| plastic surgery and in dermatology. | ||
| Regulation Number: | 21 CFR 878.4810 | |
| Product Code: | GEX | |
| Predicate devices: | MeDioStar (K192483) and LightSheer Desire | |
| (K170179) |
5
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 |
| Laser | ||||
| Wavelengths | 808 nm +/- 20 nm | 755-950 nm | 805-1060 nm | Whitin the range |
| of the predicate | ||||
| devices | ||||
| Indications for | ||||
| use | 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. | 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, | ||||
| permanent hair reduction and | ||||
| the treatment of benign | ||||
| pigmented lesions. | indicated for use in | |||
| surgical, aesthetic, and | ||||
| cosmetic applications | ||||
| in the medical | ||||
| specialties of general | ||||
| and plastic surgery, | ||||
| and dermatology. The | ||||
| LightSheer | ||||
| Desire | ||||
| System is intended for | ||||
| use on all skin types | ||||
| (Fitzpatrick skin types I | ||||
| — VI), including tanned | ||||
| skin. | ||||
| The LightSheer Desire | ||||
| System | ||||
| with | ||||
| LightSheer ET/XC | ||||
| 805nm Laser | ||||
| Handpieces are | ||||
| intended for: | ||||
| • Treatment of benign | ||||
| vascular lesions, | ||||
| including angiomas, | ||||
| hemangiomas, | ||||
| telangiectasia and | ||||
| other benign vascular | ||||
| lesions 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 of | ||||
| pseudofolliculitis | ||||
| barbae (PFB) | ||||
| Hair removal, | ||||
| permanent hair | ||||
| reduction* Treatment of benign | ||||
| pigmented lesions | ||||
| Pulse width | ||||
| (max) | 5 - 100 ms | 3 - 400 ms | Up to 400 ms | Whitin the range |
| of the predicate | ||||
| devices | ||||
| Fluence (max) | 5-90 J/cm2 | 210 J/cm² | ||
| Max. Fluence Hair reduction | ||||
| 60 J/cm² | 10-100 J/cm2 | Same as the | ||
| predicate device 2 | ||||
| Spot Size | 12, 18, 24 mm (round | |||
| diameter) respective | ||||
| area (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, | |||
| 22x35 | ||||
| respective area | ||||
| (cm²) 0.81 - 2.43 - | ||||
| 7.7 | Areas within the | |||
| range of the | ||||
| predicate devices | ||||
| Repetition Rate | ||||
| (max) | Up to 10 Hz | Up to 20 Hz | Up to 3 Hz | Whitin the range |
| of the predicate | ||||
| device 1 | ||||
| Skin Cooling | Contact skin cooling | contact skin cooling system | ||
| (metal probe cooled by a peltier | ||||
| element) | Chilltip contact cooling | Same as Predicate | ||
| devices (contact | ||||
| mode) | ||||
| Power Supply | Single phase, | |||
| 100-240V | ||||
| 50-60 Hz | Single phase, | |||
| 100-240V | ||||
| 50-60 Hz | Single phase, | |||
| 100-240V | ||||
| 50-60 Hz | Same as predicate | |||
| devices |
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):
7
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 requirements |
| for 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.