Q-PLUS T

K073549 · Quanta System Spa · GEX · Feb 28, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073549
• Device Name: Q-PLUS T
• Applicant: Quanta System Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Nd:YAG (1064nm) and (532nm) The Q-Plus T Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby (694nm) The Q-Plus T Q-Switched laser is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion. Some examples of pigment lesions are Lentigines café-au-lait-blotches Ephalides Benign Naevi such as: Naevus of Ota Naevus of Ito Epidermal Naevi Congenital Naevi Beckers Naevi Blue Nevus Naevus Spillus Mongolian Spot

Device Story

Q-Plus T is a Q-Switched laser system for dermatology. Employs Nd:YAG (1064nm/532nm) and Ruby (694nm) laser sources. Inputs: electrical power; user-selected parameters via microprocessor controller. Operation: laser energy delivered via articulated arm to target tissue; used for cutting, vaporization, ablation, and pigment/tattoo removal. Used in clinical settings by physicians. Output: laser light interaction with tissue. Benefits: precise soft tissue management and removal of pigmented lesions/tattoos. Safety features ensure correct wavelength/handpiece selection.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Q-Switched Nd:YAG laser (1000mJ at 1064nm, 500mJ at 532nm) and Q-Switched Ruby laser (1000mJ at 694nm). Articulated arm optical delivery system. Includes power supply, cooling system, and microprocessor-based controller. Safety features for wavelength/handpiece verification.

Indications for Use

Indicated for patients requiring treatment of vascular lesions, pigmented lesions, hair removal, tattoo removal, and soft tissue incision, excision, ablation, or vaporization in general dermatology. Includes treatment of specific benign naevi (e.g., Ota, Ito, epidermal, congenital, Becker's, blue, spillus, Mongolian spot), lentigines, café-au-lait blotches, and ephalides.

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 System (K050382)
• ASCLEPION LASER TECHNOLOGIES GmbH TattooStar R (K060787)

Submission Summary (Full Text)

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K073549

## 510(k) SUMMARY Quanta System Q-Plus T

| Submitter: | Quanta System SpA<br>via IV Novembre,116<br>21058 Solbiate<br>Olona VA / Italy |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Isabella Carrer<br>Medical Division Manager |
| Date Prepared: | June 28, 2007 |
| Device Trade Name: | Quanta System Q-Plus T |
| Common Name: | Laser surgical instrument for use in general surgery and<br>dermatology |
| Classification Name: | Instrument, surgical, powered, laser |
| Predicate Devices: | - Cynosure, Inc Affinity QS Q-Switched Nd:YAG<br>Laser System (K050382);<br>- ASCLEPION LASER TECHNOLOGIES GmbH<br>TattooStar R (K060787 ) |
| Intended Use /<br>Indications for Use: | Nd:YAG (1064nm) and (532nm)<br>The Q-Plus T Q-Switched laser is intended for<br>treatment of vascular lesions, pigmented lesions, and<br>for hair, tattoo removal and the incision, excision,<br>ablation, vaporization of soft tissue for general<br>dermatology. |
| | Ruby (694nm) |
| | The Q-Plus T Q-Switched laser is intended for use for<br>cutting, vaporization and ablation of soft tissue and the<br>removal of tattoos and benign pigment lesion. |
| | Some examples of pigment lesions are |
| | <ul><li>Lentigines</li><li>café-au-lait-blotches</li></ul> |

Title:

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- 트 Ephalides
- Benign Naevi such as: 트
- Naevus of Ota .
- Naevus of Ito 8
- l Epidermal Naevi
- 포 Congenital Naevi
- l Beckers Naevi
- I Blue Nevus
- l Naevus Spillus
- I Mongolian Spot

Technological The device includes a Q-Switched Nd:YAG laser source Characteristics: with 1000mJ max energy at 1064 nm and 500mJ max energy at 532 nm wavelengths, and a Q-Switched Ruby laser source with 1000mJ max energy at 694nm wavelength. The optical delivery system for the three wavelengths is the articulated arm. In addition, the Q-Plus T includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece. None Performance Data

The Quanta System O-Plus-T is as safe and effective as Substantial the predicate devices. The Q-Plus T has the same Equivalence: intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Q-Plus T and its predicate devices raise no new issues of safety or effectiveness. Thus, the Q-Plus T is substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard FEB 2 8 2008 Rockville MD 20850

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

Re: K073549 Trade/Device Name: Q-Plus T 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: February 18, 2008 Received: February 19, 2008

Dear Mr. Job:

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. Ilsting 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 such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological 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):

Q-Plus T Device Name:

Indications for Use:

## Nd:YAG (1064nm) and (532nm)

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

## Ruby (694nm)

The Q-Plus T Q-Switched laser is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.

Some examples of pigment lesions are

- 트 Lentigines
- café-au-lait-blotches 에
- Ephalides 트
- l Benign Naevi such as:
- Naevus of Ota 트
- Naevus of Ito ■
- l Epidermal Naevi
- . Congenital Naevi
- Beckers Naevi 트
- 트 Blue Nevus
- Naevus Spillus I
- I Mongolian Spot

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

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

Mark A. Millman

(PLEASE DO NOT WRITE BELOW THIS LINE --IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (C

510(k) Number K0739