ASA 'MPHI FAMILY DIODE LASER

K111901 · Cynosure, Inc. · ILY · Nov 9, 2011 · Physical Medicine

Device Facts

• Record ID: K111901
• Device Name: ASA 'MPHI FAMILY DIODE LASER
• Applicant: Cynosure, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Nov 9, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ASA 'Mphi Family' Diode Laser is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Device Story

The ASA 'Mphi Family' Diode Laser is a therapeutic device emitting 808 nm and 905 nm infrared wavelengths to provide topical heating. The device is operated by a user via a selectable controller. It functions by elevating tissue temperature to achieve therapeutic effects, including pain relief, increased local blood circulation, and muscle relaxation. It operates on 110-250VAC power or battery mode. The device is intended for clinical use to assist healthcare providers in managing musculoskeletal conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Diode laser system; wavelengths 808 nm and 905 nm; power input 110-250VAC, 50-60Hz, 50VA or battery operation; user-selectable controller for laser emission activation.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of muscle/joint pain, stiffness, arthritis pain, muscle spasm, increased local blood circulation, or muscle relaxation.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• ASA 'M Family' Diode Laser

Submission Summary (Full Text)

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K 111901 - 111901

## NOV - 9 2011

## 510(K) Summary

| Submitter: | ASA srl<br>Via Volta, 9<br>36057 ARCUGNANO (VI)<br>ITALY |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lucio Zaghetto, President ASA srl<br>c/o Cynosure, Inc.<br>5 Carlisle Road<br>Westford, MA 01886 |
| Date Summary Prepared | June 30, 2011 |
| Device Trade Name | ASA 'Mphi Family' Diode Laser |
| Common Name | Infrared Lamp 21 CFR 890.5500 |
| Equivalent Devices: | ASA 'M Family' Diode Laser |
| Device Description | The ASA 'Mphi Family' Diode Lasers provides 808 and 905 nm<br>wavelengths.<br>Laser emission activation is by the user selectable controller.<br>Electrical requirement is 110-250VAC, 50VA, 50-60Hz, single<br>phase or battery mode. |
| Intended Use | The ASA 'Mphi Family' Diode Lasers is intended to provide<br>topical heating for the purpose of elevating tissue temperature for<br>temporary relief of muscle and joint pain and stiffness, arthritis<br>pain, or muscle spasm, the temporary increase in local blood<br>circulation and/or promoting relaxation of muscle. |
| Comparison: | The ASA 'Mphi Family' Diode Lasers has the same indications<br>for use , the same principle of operation, and identical<br>performance specifications as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data | none |
| Conclusion | The ASA 'Mphi Family' Diode Lasers is a safe and effective<br>device for the indications specified. |
| Additional information: | none |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, oriented towards the upper right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

NOV - 9 2011

ASA srl % Cynosure, Inc. Mr. Anthony Burns Director of Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886

Re: K111901

Trade/Device Name: ASA 'Mphi Family' Diode Laser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: October 11, 2011 Received: October 13, 2011

Dear Mr. Burns:

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.

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Page 2 - Mr. Anthony Burns

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 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/CDRHQffices/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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

FOR Peter O. Rimm
Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Numer (if know): K111901

Device Name: ASA 'Mphi Family' Diode Laser

Indication For Use:

The ASA 'Mphi Family' Diode Laser is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Prescriptive Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use OR (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(K) Number K///98/