Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376912.htm
Timestamp: 2019-04-22 16:20:26+00:00

Document:
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.
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).

References: § 321
 § 351
 § 360
 § 360
 § 352
 § 360