Hyperion Medical 11/20/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire A venue|
Silver Spring. MD 20993
November 20, 2013
VIA UNITED PARCEL SERVICE
4608 Nashwood Lane
Dallas, Texas 75244
Re: HyperBlue 1530/Blueshine Gold Series
Refer to CPT1300261
Dear Mr. Day:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing surgical lasers (the HyperBlue 1530 and Blueshine Gold Series) in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
The FDA has reviewed your firm’s websites, www.hyperionmed.com/hyperblue.html and www.blueshine.biz, and determined that the HyperBlue 1530 and Blueshine Gold Series devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). These devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution in that a notice or other information respecting the modification to the devices was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(i). Specifically, your firm modified the Blueshine Gold Series for the 980 nm wavelength, cleared under section 510(k) as K110375, by claiming that the device can also use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with otherwavelengths. Additionally, your firm has added a 15mm hand piece to the HyperBlue 1530 device. These modifications require a new submission under section 510(k) of the Act because the addition of new wavelengths and hand pieces, when used with the cleared device, introduces additional safety and effectiveness questions.
For a device requiring premarket approval, the notification required by section 510(k) of the Act is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm
. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our office requests that Hyperion Medical immediately cease activities that result in the misbranding or adulteration of theHyperBlue 1530 and Blueshine Gold Series devices, such as the commercial distribution of the devices for the uses discussed above.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Operations Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number CPT1300261when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Ms. LaShanda Long at (301)796-5465 or (301) 847-8137 (fax).
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
Steven D. Silverman
Office of Compliance
Center for Devices and