QUADROSTARPROGREEN, QUADROSTARPROYELLOW

K133297 · Asclepion Laser Technologies GmbH · GEX · Jun 10, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133297
• Device Name: QUADROSTARPROGREEN, QUADROSTARPROYELLOW
• Applicant: Asclepion Laser Technologies GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The QuadroStarPROYELLOW (wavelength: 577nm) is intended for treatment of benign vascular and benign pigmented lesions. The QuadroStarPROGREEN (wavelength: 532nm) is intended for vaporisation and photocoagulation of benign vascular and benign pigmented lesions in soft tissue. Federal law restricts this device to sale by or on the order of a physician!

Device Story

QuadroStarPRO is a Class IV solid-state diode laser system emitting 577 nm or 532 nm wavelengths. System components include a control panel, foot switch, transfer fiber, handpiece, and optional scanner. Operated by physicians in clinical settings, the device delivers laser energy to tissue for vaporization and photocoagulation. The system uses internal air cooling and supports pulsed or continuous wave (cw) operation. Physicians use the device to treat benign vascular and pigmented lesions; the laser energy targets specific tissue chromophores to achieve therapeutic effects. The device is intended for professional use only.

Clinical Evidence

Bench testing only. Compliance with standards including ISO 14971, DIN EN 60601-1, DIN EN 60601-1-2, DIN EN 60601-1-6, DIN EN 60601-2-22, DIN EN 60825-1, and DIN EN 62304.

Technological Characteristics

Solid-state diode laser; wavelengths 577 nm or 532 nm; max power 8 W (532 nm) or 5 W (577 nm); pulse duration 1 ms - 95 s and cw; internal air cooling; power supply 100-240VAC; delivery via transfer fiber/handpiece/optional scanner. Complies with DIN EN 60601 series and DIN EN 60825-1.

Indications for Use

Indicated for patients requiring treatment of benign vascular and benign pigmented lesions in soft tissue using 577nm or 532nm laser wavelengths.

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

• YellowStar Asclepion-Meditec AG (K013940)
• QuadroStar 532 Asclepion Laser Technologies GmbH (K060457)

Submission Summary (Full Text)

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## JUN 1 0 2014

## 510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH K133297 QuadroStarPRO

This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH QuadroStarPRO is submitted in accordance with the requirements of 21 CFR 907.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.

| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbH<br>Bruesseler Str. 10<br>07747 Jena, Germany |
|----------------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Mrs. Antje Katzer<br>Product Management and<br>International Regulatory Affairs |
| Phone: | [phone] |
| Fax: | [phone] |
| e-mail: | [e-mail] |
| Preparation Date: | June 10, 2014 |
| Device Name: | QuadroStarPRO |
| Common Name: | QuadroStarPRO |
| Classification Name: | Laser surgical instrument for use in general and plastic<br>surgery<br>79-GEX<br>21 CFR 878.4810 |

Equivalent Devices:

| K013940 | YellowStar Asclepion-Meditec AG<br>(Assignor of Asclepion Laser Technologies GmbH) |
|---------|------------------------------------------------------------------------------------|
| K060457 | QuadroStar 532 Asclepion Laser Technologies GmbH |

The QuadroStarPRO Laser system is a laser Class IV, Device Description: solid state diode laser, which emits laser radiation with a wavelength of either 577 nm or 532 nm. It`s pulse duration can be varied from millisecond pulses up to continuous operation. The laser power up to 8 Watts is transmitted to the tissue through a transfer fiber and a handpiece, optionally a scanner can be operated.

The laser system consists of:

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Laser system including control panel (user interface) Foot switch A transfer fiber with handpiece, optional different spacers. The QuadroStarPROYELLOW (wavelength: 577nm) is Intended Use: intended for treatment of benign vascular and benign pigmented lesions. The QuadroStarPROGREEN (wavelength: 532nm) is intended for vaporisation and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.

Comparison to:

The QuadroStarPRO with 577 nm has identical indications for use as the K013940 YellowStar, the QuadroStarPRO with 532 nm has identical indications for use as the K060457 QuadroStar 532.

Therefore the QuadroStarPRO is found to be substantially equivalent to already marketed and predicate lasers. Both predicates were developed by Asclepion or it's assignor.

With regard to technology, the QuadroStarPRO is found to be substantially equivalent to K060457 QuadroStar 532, since the basic technology, design and safety features are very similar. With the availability of multi-color diodes it became practicable also to generate wavelengths such as 577 nm by means of modern diode

technology, whereas in former times these wavelengths could only be generated with the technology of Copper Bromide or Copper Vapor lasers.

The differences between QuadroStarPRO and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

| Device | QuadroStarPRO | K013940<br>YellowStar | K060457<br>QuadroStar 532 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| | | | |
| Intended Use | 577 nm: intended for<br>treatment of benign<br>vascular and benign<br>pigmented lesions.<br>532 nm: intended for<br>vaporisation and<br>photocoagulation of benign<br>vascular and benign<br>pigmented lesions in soft<br>tissue. | Intended for treatment<br>of vascular and<br>pigmented lesions. | Intended for vaporization<br>and photocoagulation of<br>vascular and pigmented<br>lesions in soft tissue. |
| Device Type | Diode pumped solid-state<br>laser | Copper Bromide laser | Diode pumped solid-state<br>laser |
| Wavelength | 532 nm or 577 nm<br>(cannot be combined) | 511 nm and 578 nm<br>(single or combined) | 532 nm |
| Principle of<br>operation | Pulsed or cw<br>Optical excitation | Pulsed or Quasi-<br>continuous<br>High voltage<br>excitation | Pulsed or cw<br>Optical excitation |
| Maximum | 8 W (532 nm) | 5 W (511 nm) | 5 W |

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| Power | 5 W (577 nm) | 2 W (578 nm)<br>7 W both/combined | |
|----------------------------|-------------------------------------------------------|-----------------------------------|----------------------|
| Energy Range | Up to 1.9 J | Up to 0.4 J | Up to 12.4 J |
| Device | | K013940 | K060457 |
| | QuadroStarPRO | YellowStar | QuadroStar 532 |
| Pulse Duration | 1 ms - 95 s and cw | 10 - 950 ms and cw | 5 ms - 2.5 s and cw |
| Max.<br>Repetition<br>Rate | 20 Hz | 16 kHz Quasi-cw | 120 Hz |
| Delivery | Transfer fiber | Transfer fiber | Transfer fiber |
| Spot<br>diameters | 1 mm / optional :<br>0.5/1.5/2.8 mm<br>Scanner : 1 mm | 0.2/0.4/0.6/1.0/1.5 mm | 0.5/1.0/1.5 mm |
| Device<br>Cooling | Internal air cooling | Internal air cooling | Internal air cooling |
| Power Supply | 100 - 240VAC, 50/60Hz | 230V 50/60Hz/10 A | 115/230V 50/60Hz |

Performance Testing:

The QuadroStarPRO laser system is tested according to following standards:

ISO 14971:2009 DIN EN 60601-1:2006 DIN EN 60601-1-2:2007 DIN EN 60601-1-6:2007 DIN EN 60601-2-22:1996 DIN EN 60825-1:2007 DIN EN 62304:2006

The device also complies with European Medical Device Directive 93/42/EEC + Amendment 2007/47/EC.

Conclusion: The QuadroStarPRO is substantially equivalent to the cited legally marked predicate devices. The minor differences between QuadroStarPRO and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 10, 2014

ASCLEPION LASER TECHNOLOGIES GmbH Ms. Antje Katzer Product Management and International Regulatory Affairs Bruesseler Str. 10 07747 Jena. Germany

Re: K133297 Trade/Device Name: QuadroStarPRO 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: May 7, 2014 Received: May 12, 2014

Dear Ms. Katzer:

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 (reporting of medical

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Page 2 - Ms. Antje Katzer

device-related 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 [phone] or [phone] or at its Internet address

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

for

Sincerely yours,

## David Krause -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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | |
| Form Approved: | OMB No. 0910-0120 |
| Expiration Date: | January 31, 2017<br>See PRA Statement below. |
| 510(k) Number ( <i>if known</i> ) | K133297 |
| Device Name | QuadroStarPRO |
| Indications for Use (Describe) | The QuadroStarPROYELLOW (wavelength: 577nm) is intended for treatment of benign vascular and benign pigmented lesions. |
| | The QuadroStarPROGREEN (wavelength: 532nm) is intended for vaporisation and photocoagulation of benign vascular and benign pigmented lesions in soft tissue. |
| Federal law restricts this device to sale by or on the order of a physician! | |
| Type of Use ( <i>Select one or both, as applicable</i> ) | |
| <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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) | |
| Neil R Ogden | |
| 2014.06.10 15:45:00 -04'00' | For BSA |
| 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<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br>[e-mail] | |
| <i>"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."</i> | |

FORM FDA 3881 (1/14)

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