Quanta Forte

K152714 · Quanta System Spa · GEX · Dec 21, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K152714
• Device Name: Quanta Forte
• Applicant: Quanta System Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Quanta Forte and its Hand Pieces are intended for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery. Quanta Forte with 808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*. Quanta Forte with 415-950nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale. Quanta Forte with 535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick Scale. Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale. Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale. Quanta Forte with 635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Hair removal and Permanent Hair Reduction* in all skin types (I-VI) to the Fitzpatrick scale. Quanta Forte with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). Quanta Forte with 1064 nm Long Pulse (LP) Nd: Y AG Laser Handpiece is indicated for: Removal of unwanted hair, for stable long-term, or permanent, hair reduction* through selective targeting of melanin in hair follicles. Removal or lightening of unwanted hair (with and without adjuvant preparation) Treatment of pseudofolliculitis barbae (PEB) * Permanent hair reduction is defined as the 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.

Device Story

Quanta Forte is a multi-modality console system utilizing interchangeable handpieces for laser and Intense Pulsed Light (IPL) therapy. Input consists of user-selected parameters via a graphic user interface; system controller manages energy delivery. Handpieces include 808nm diode, 1064nm Nd:YAG, 2940nm Er:YAG lasers, and various IPL sources (415-950nm, 535-950nm, 580-950nm, 635-950nm). Operated by clinicians in dermatology/plastic surgery settings; triggered via footswitch or finger switch. Device delivers light/laser energy to skin for therapeutic effects like hair reduction, lesion treatment, and tissue resurfacing. Benefits include non-invasive or minimally invasive treatment of dermatological conditions. Output is controlled energy delivery; healthcare providers use this to perform selective tissue treatments.

Clinical Evidence

Bench testing only. Evidence includes electrical safety and electromagnetic compatibility (EMC) testing per IEC 60601-1-2, IEC 60601-2-22, and IEC 60601-2-57 standards. Software verification and validation were performed per FDA guidance.

Technological Characteristics

Console-based system with interchangeable handpieces. Energy sources: Laser (808nm diode, 1064nm Nd:YAG, 2940nm Er:YAG) and IPL (415-950nm, 535-950nm, 580-950nm, 635-950nm). Features contact-cooling on select IPL handpieces. Microprocessor-based controller for system functions and GUI. Complies with IEC 60601-1-2 (EMC), IEC 60601-2-22, and IEC 60601-2-57 (safety).

Indications for Use

Indicated for patients requiring aesthetic, surgical, or cosmetic dermatological treatments. Specific indications include benign vascular/pigmented lesions, inflammatory acne (Fitzpatrick I-V), hair removal/reduction, skin resurfacing, wrinkle treatment, and scar revision. Contraindications are not explicitly listed, though skin type limitations (Fitzpatrick I-VI) apply to specific handpieces.

Regulatory Classification

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.

Predicate Devices

• Mediostar Next Family (K143519)
• Omnimax (K111303)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and uses a single color, which appears to be black.

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

December 21, 2015

Quanta System SPA Francesco Dell'antonio Head of Regulatory Affairs Department Via IV Novembre, 116 Solbiate Olona (VA), 21058 IT

Re: K152714 Trade/Device Name: Quanta Forte 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, ONF Dated: November 23, 2015 Received: December 3, 2015

Dear Mr. 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 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 CFR 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

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Binita S. Ashar -S

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K152714

Device Name Quanta Forte

#### Indications for Use (Describe)

Ouanta Forte and its Hand Pieces are intended for use in aesthetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.

Quanta Forte with 808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.

Quanta Forte with 415-950nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale.

Quanta Forte with 535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Pigmented and Vascular Lesions in all skin types (1-VI) to the Fitzpatrick Scale.

Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale.

Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale.

Quanta Forte with 635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Hair removal and Permanent Hair Reduction* in all skin types (1-VI) to the Fitzpatrick scale.

Quanta Forte with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to:

Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

Quanta Forte with 1064 nm Long Pulse (LP) Nd: Y AG Laser Handpiece is indicated for:

· Removal of unwanted hair, for stable long-term, or permanent, hair reduction* through selective targeting of melanin in hair follicles.

· Removal or lightening of unwanted hair (with and without adjuvant preparation)

· Treatment of pseudofolliculitis barbae (PEB)

* Permanent hair reduction is defined as the 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.

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)

{3}------------------------------------------------

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 5. 510(K) SUMMARY

## Introduction:

This document contains the 510(k) Summary for the Quanta Forte device. The content of this summary is based on the requirements of 21 CFR 807.92(c).

| Applicant / Manufacturer Name and Address: | Quanta System SPA Via IV Novembre, 116 Solbiate Olona (VA) Italy, 21058 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Francesco Dell'Antonio Head of Regulatory Affairs dept Quanta System SPA Email: [e-mail] Phone: [phone] Fax: [phone] |
| Date Prepared: | 14/09/2015 |
| Device Name: | Quanta Forte |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |

Predicate Devices:

Quanta Forte is substantially equivalent to the following legally marketed predicate devices:

- K143519 Mediostar Next Family - Asclepion Laser Technologies Gmbh
- . K111303 Omnimax - Sharplight Technologies Ltd

### Description of the device:

Quanta Forte system is an Intense Pulsed Light (IPL) and laser emitting device that is operated with a handpiece in contact with the skin.

Quanta Forte comprises a main console unit and several handpieces that are triggered by means of a footswitch or a finger switch.

A microprocessor based system controller is used to monitor and direct all the system functions and the graphic user interface.

{5}------------------------------------------------

The main console can be connected to the following handpieces:

- -415-950 nm Intense Pulsed Light
- 535-950 nm Intense Pulsed Light .
- -580-950 nm Intense Pulsed Light
- -635-950 nm Intense Pulsed Light
- -808 nm laser diode
- -1064 nm ND:YAG laser
- -2940 nm Erbium:YAG laser

### Intended use

Quanta Forte and its Hand Pieces are intended for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.

Quanta Forte with 808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.

Quanta Forte with 415-95onm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne vulgaris) in skin types (I-V) to the Fitzpatrick scale.

Quanta Forte with 535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick Scale.

Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale.

Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale.

Quanta Forte with 635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Hair removal and Permanent Hair Reduction* in all skin types (I-VI) to the Fitzpatrick scale.

Quanta Forte with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to:

Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

Quanta Forte with 1064 nm Long Pulse (LP) Nd:YAG Laser Handpiece is indicated for: Removal of unwanted hair, for stable long-term, or permanent, hair reduction* through selective targeting of melanin in hair follicles.

{6}------------------------------------------------

Removal or lightening of unwanted hair (with and without adjuvant preparation) Treatment of pseudofolliculitis barbae (PEB)

* Permanent hair reduction is defined as the 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.

# Comparison of Technological Characteristics:

Quanta Forte has the same technological characteristics (energy source, laser/IPL source, control mechanism) and specifications as its predicate devices.

# Performance data:

The following performance data are provided in support of the substantial equivalence determination:

### Safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Quanta Forte device. The system complies with the IEC 60601-2-22, IEC 60601-2-22, IEC 60601-2-57 standards for safety and the IEC 60601-1-2 standard for EMC.

# Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

# Comparison of Intended Use:

Quanta Forte device's Intended Use combines the Intended Uses of its predicate devices.

# Substantial Equivalence:

The Quanta Forte device is as safe and effective as its predicate devices. The Quanta Forte device has the same intended use and same technological characteristics and specifications as its predicate devices.

Thus, Quanta Forte device is substantially equivalent to its predicate devices.