QUANTA SYSTEM DUOLITE

K103539 · Quanta System Spa · GEX · Jan 20, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103539
• Device Name: QUANTA SYSTEM DUOLITE
• Applicant: Quanta System Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (blue, black and green tattoo) The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)

Device Story

The Quanta System DUOLITE is a Q-Switched Nd:YAG laser surgical instrument used in dermatology. It utilizes 1064 nm and 532 nm wavelengths to treat vascular and pigmented lesions, remove hair, and perform soft tissue surgery (incision, excision, ablation, vaporization). The device includes a laser source, power supply, cooling system, and an articulated arm optical delivery system. A microprocessor-based controller manages laser parameters, including wavelength and handpiece selection, ensuring safety. Operated by clinicians in a clinical setting, the device delivers pulsed laser energy to the target tissue. The output allows for precise tissue interaction, enabling dermatological procedures and tattoo removal. The system is designed to provide controlled energy delivery to achieve therapeutic outcomes in skin and tissue management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance comparisons to the predicate device.

Technological Characteristics

Q-Switched Nd:YAG laser; wavelengths 1064 nm and 532 nm; pulse width 6 ns; fluence up to 28 J/cm² (1064 nm) and 14 J/cm² (532 nm); spot sizes 2, 3, 6 mm; repetition rates 1, 2, 5, 10 Hz. Includes microprocessor-based controller, cooling system, and articulated arm delivery. Biocompatible handpiece materials.

Indications for Use

Indicated for patients requiring treatment of vascular lesions, pigmented lesions, hair removal, and soft tissue incision, excision, ablation, or vaporization in general dermatology, as well as removal of blue, black, green, red, violet, orange, yellow, and brown tattoos.

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

• Cynosure, Inc Affinity QS Q-Switched Nd: YAG Laser (K050382)

Submission Summary (Full Text)

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K103539

## 510(k) SUMMARY Quanta System DUOLITE

Laser surgical instrument for use in general surgery and

Cynosure, Inc Affinity QS Q-Switched Nd: YAG Laser

tattoo removal ( blue, black and green tattoo)

wavelengths is the articulated arm.

The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE O-Switched laser is intended for

The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)

The device includes a Q-Switched Nd: YAG laser source with

532 nm wavelengths. The optical delivery system for the two

In addition, the DUOLITE includes a power supply; a cooling system; an optical delivery system; a microprocessor based

900mJ max energy at 1064 nm and 450mJ max energy at

controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece.

Submitter:

Contact:

Title:

Quanta System SpA via IV Novembre, 1 16 21058 Solbiate Olona VA / Italy

Dr. Maurizio Bianchi QA and Regulatory Affairs Manager

Instrument, surgical, powered, laser

February 28, 2013

System (K050382);

Nd:YAG (1064nm):

Nd:YAG (532nm):

None

Dermatology

Date Prepared:

Quanta System DUOLITE Device Trade Name:

Common Name:

Classification Name:

Predicate Devices:

Intended Use / Indications for use:

Technological Characteristics:

Performance data:

Substantial Equivalence: The Quanta System DUOLITE is as safe and effective as the predicate devices. The DUOLITE has the same intended uses and similar indications, technological characteristics,

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| | Wavelength<br>[nm] | pulse<br>width<br>[ns] | Fluence<br>[J/cm²] | spot<br>size<br>[mm] | Rep.<br>rate<br>[Hz] |
|--------------------------------------|--------------------|------------------------|---------------------------------------------------------------------|----------------------|----------------------|
| QUANTA<br>SYSTEM<br>DUOLITE | 1064 nm | 6 ns | 28J/cm² at 2mm<br>12J/cm² at 3mm<br>3J/cm² at 6mm | 2,3 and<br>6mm | 1,2,5<br>and<br>10Hz |
| | 532 nm | 6 ns | 14J/cm² at 2mm<br>6J/cm² at 3mm<br>1,5J/cm² at 6mm | 2,3 and<br>6mm | 1,2,5<br>and<br>10Hz |
| CYNOSURE<br>AFFINITY<br>QS (K050382) | 1064 nm | 6 ns | 28J/cm² at 2mm<br>12J/cm² at 3mm<br>7J/cm² at 4mm<br>3J/cm² at 6mm | 2,3,4<br>and<br>6mm | 1,2,5<br>and<br>10Hz |
| | 532 nm | 6 ns | 14J/cm² at 2mm<br>6J/cm² at 3mm<br>3J/cm² at 4mm<br>1,5J/cm² at 6mm | 2,3,4<br>and<br>6mm | 1,2,5<br>and<br>10Hz |

and principles of operation as its predicate device as demonstrated in the table below.

The tip of the handpiece of the DUOLITE is made of Biocompatible material as the predicate device. This Sterilization method is the same as its predicate device. The Minor technological differences between the DUOLITE and its predicate devices raise no new issue of safety or effectiveness. Thus, the DUOLITE is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

Quanta System, S.P.A. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313

March 15, 2013

Re: K103539 Trade/Device Name: DUOLITE 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: January 06, 2011 Received: January 07, 2011

Dear Mr. Job:

This Letter corrects our substantially equivalent letter of January 20, 2011.

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 (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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Mark Job

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/ucm115809.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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

> Sincerely yours, FOR

## Peter D. Rumm -S

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 Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

DUOLITE Device Name:

Indications for use:

Nd:YAG (1064nm):

The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (blue, black and green tattoo)

Nd: YAG (532nm):

The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)

Neil R Ogdens 2013.03.15 12:54:24 -04'00'

(Division Sign Off) for MXM Division of Surgical, Orthopedic, And Restorative Devices

510(k) Number K103539 .

Prescription Use AND/OR ਮ (Part 21 C.F.R. 801 Subpart D)

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)