(127 days)
The ASA 'Mphi Family' Diode Laser is intended to provide topical heating for the purpose of elevating tissue temperature for 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.
The ASA 'Mphi Family' Diode Lasers provides 808 and 905 nm wavelengths. Laser emission activation is by the user selectable controller. Electrical requirement is 110-250VAC, 50VA, 50-60Hz, single phase or battery mode.
The provided text is a 510(k) summary for the ASA 'Mphi Family' Diode Laser. It explicitly states:
"Nonclinical Performance Data: none"
"Clinical Performance Data: none"
Therefore, there is no information within the provided document to address any of the points regarding acceptance criteria or a study proving the device meets those criteria. The submission relies entirely on demonstrating substantial equivalence to a predicate device, which had "the same indications for use, the same principle of operation, and identical performance specifications."
Conclusion:
Based on the provided K111901 document, there is no information available regarding acceptance criteria or a study demonstrating the device meets such criteria. The submission is based solely on a comparison to a predicate device, and it explicitly states that no nonclinical or clinical performance data was provided.
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K 111901 - 111901
NOV - 9 2011
510(K) Summary
| Submitter: | ASA srlVia Volta, 936057 ARCUGNANO (VI)ITALY |
|---|---|
| Contact: | Lucio Zaghetto, President ASA srlc/o Cynosure, Inc.5 Carlisle RoadWestford, 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 nmwavelengths.Laser emission activation is by the user selectable controller.Electrical requirement is 110-250VAC, 50VA, 50-60Hz, singlephase or battery mode. |
| Intended Use | The ASA 'Mphi Family' Diode Lasers is intended to providetopical heating for the purpose of elevating tissue temperature fortemporary relief of muscle and joint pain and stiffness, arthritispain, or muscle spasm, the temporary increase in local bloodcirculation and/or promoting relaxation of muscle. |
| Comparison: | The ASA 'Mphi Family' Diode Lasers has the same indicationsfor use , the same principle of operation, and identicalperformance specifications as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data | none |
| Conclusion | The ASA 'Mphi Family' Diode Lasers is a safe and effectivedevice 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 (800) 638-2041 or (301) 796-7100 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/
N/A