The THUNDER Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

1064 nm (pulsed)
Dermatology/Plastic Surgery:
Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.
The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The laser is also indicated for the treatment of facial wrinkles.
Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months affer the completion of a treatment regime.
It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
It is indicated for use on all skin types (Fitzpatrick I-VI ) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

755 nm (pulsed)
Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

Skin Cooler
The intended use of the integrated cooling system in the Thunder family is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

Device Description

This Special 510(k) of the modified device Thunder family is submitted due to Device Modifications of the already cleared device EVO family (K160368) due to hardware and software change, together with a broadening of the range of some laser emission parameters.

AI/ML Overview

This document details a 510(k) premarket notification for the "Thunder" family of laser devices, focusing on modifications made to an already cleared device, the "EVO family" (K160368). The submission aims to demonstrate substantial equivalence to the predicate device despite hardware and software changes and a broadening of laser emission parameters.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "There are no mandatory performance standards for this device." This implies that specific quantitative acceptance criteria in terms of device accuracy, sensitivity, or specificity (as one might find for diagnostic AI models) are not applicable or provided within this submission.

Instead, the acceptance criteria are framed in terms of compliance with established safety and performance standards for medical electrical equipment and laser products. The reported "performance" is that the modified device "successfully passed" these tests.

Acceptance Criteria Type	Specific Criteria/Standard	Reported Device Performance
Safety	IEC 60601-1: 2012 (General requirements for basic safety and essential performance)	Passed
	IEC 60601-1-2:2014 (Electromagnetic disturbances - Requirements and tests)	Passed
	IEC 60601-2-22:2007+ A1:2012 (Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)	Passed
	IEC 60825-1: 2014 (Safety of laser products -- Part 1: Equipment classification and requirements)	Passed
Usability	EN 60601-1-6:2010 + A1:2013 (General requirements for basic safety and essential performance - Collateral Standard: Usability)	Passed
Functional/Hardware	Evidence that "hardware and software change, together with a broadening of the range of some laser emission parameters" does not alter the intended use or safety/effectiveness compared to the predicate device. This is implicitly tested by passing the safety/EMC tests.	Device maintains same intended use as unmodified device.
Software	Software verifications and validation (as per internal protocols and relevant standards, implicitly covered by IEC 60601 series)	Successfully passed

2. Sample Size Used for the Test Set and Data Provenance:

No information is provided regarding a "test set" in the context of clinical data or patient samples. The testing described is against engineering and safety standards, not a clinical dataset. Therefore, there is no mention of sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). This device is a laser system for surgical/dermatological applications, not a diagnostic AI device requiring clinical ground truth for validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. The "ground truth" for this device revolves around its compliance with safety and performance engineering standards, not medical diagnoses. Therefore, there's no mention of experts establishing a clinical ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable. This device is a laser system for treatment, not a diagnostic tool that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable in the typical sense of an AI algorithm. The device, as a laser system, operates "standalone" in that its hardware and software functions are tested independently of a human operator making a diagnostic decision. However, its intended use is always with a human operator. The performance testing focuses on the device's adherence to engineering specifications and safety standards as an independent unit.

7. The Type of Ground Truth Used:

The ground truth used for this device is compliance with established international and harmonized engineering and safety standards (e.g., IEC 60601 series, IEC 60825-1). This is a technical "ground truth" as opposed to a clinical or pathological ground truth:

Safety Standards: Adherence to defined limits for electrical safety, EMI/EMC, laser output, etc.
Performance Standards: The device meets its specified technical parameters (e.g., laser wavelength, power, pulse duration) within acceptable tolerances, which is evaluated during performance testing.
Usability Standards: The device's user interface and operational aspects meet usability requirements.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device (laser system), not an AI model trained on a dataset. There is no concept of a "training set" for the device itself or its modifications as described in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 7, 2017

Quanta System S.p.A. Francesco Dell'antonio V.P Regulatory Affairs & Quality Assurance Via acquedotto. 109 Samarate, 20826 Italy

Re: K171711

Trade/Device Name: Thunder, Thunder VT, Thunder HR 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: February 1, 2017 Received: June 9, 2017

Dear Francesco Dell'antonio:

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 Actinclude 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 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Sincerelv. Jennifer R. Stevenson -ડેરે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપર તાલુકામ ગામનાં મુખ્યત્વે આવેલું એક ગામના લોકોનો મુ For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K171711

Device Name THUNDER Family

Indications for Use (Describe)

1064 nm (pulsed)

Dermatology/Plastic Surgery:

Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, nort wine stains. hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.

The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.

The laser is also indicated for the treatment of winkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles.

Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The laser is also indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

It is indicated for use on all skin types (Fitzpatrick I-VI ) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

755 nm (pulsed)

Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

Skin Cooler

The intended use of the integrated cooling system in the Thunder family is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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5. Special 510(K) SUMMARY - Device Modifications

Introduction:

This document contains the 510(k) Summary for Thunder family. The basis of this submission is the modifications of an already cleared family of devices. The content of this summary is based on the requirements of 21 CFR 807.92(c).

Applicant / Manufacturer Name and Address:	Quanta System SPAVia Acquedotto, 109Samarate (VA)Italy, 21017
510(k) Contact Person:	Francesco Dell'AntonioVice President Regulatory Affairs and QAQuanta System SPAEmail: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	May 11th 2017
Device Name:	Thunder family
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
Basis for Submission:	Device modifications
Legally Marketed Device	EVO family (K160368)

Performance Standards:

There are no mandatory performance standards for this device.

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Description of the modifications:

The modified device has the same intended use of the unmodified device. Moreover the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.

Based on the nature of the changes implemented, the device underwent and successfully passed electrical safety, EMC, performance testing and software verifications and validation according to the relevant standards.

Intended Use/Indications for Use

The modified device Thunder family has the same intended use of the unmodified device, as follows:

1064 nm (pulsed)

Dermatology/Plastic Surgery:

Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.

The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

The laser is also indicated for the treatment of facial wrinkles.

It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

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It is indicated for use on all skin types (Fitzpatrick I-VI ) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

755 nm (pulsed)

Skin Cooler

Substantial Equivalence:

Thunder family has the same intended use, the same fundamental scientific technology and equivalent performances as its predicate devices, therefore it is substantially equivalent to its predicate devices.

The results of the performances tests, of the basic safety tests and electrical tests do not raise any issue about safety and effectiveness of the modified device: thus the modified device is as safe and effective as the unmodified device.

The modified device Thunder family is substantially equivalent to its identified predicate devices.

Performace testing

The modified device Thunder family was subjected to performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances:

IEC 60601-1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

EN 60601-1-6:2010 + A1:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

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IEC 60601-2-22:2007+ A1:2012 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

The modified device Thunder family passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards.

Regulation Number and Section

§ 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.