Item 8 - Other Events.
On July 2, 2020, the Company received notice from the U.S. Food & Drug
Administration ("FDA") stating that the FDA has reviewed the Section 510(k)
premarket notification of intent to market filed by the Company's subsidiary,
Psoria-Shield, Inc. ("PSI"), for PSI's AURORA device and has determined that the
device is substantially equivalent to legally marketed predicate devices
marketed in interstate commerce prior to May 28, 1976, the enactment date of the
Medical Device Amendments, that do not require approval of a premarket approval
application (PMA), and may therefore, market the device, subject to the general
controls provisions of the Act. The AURORA device is indicated for use in
targeted PUVA photochemistry and UVB phototherapy for the treatment of skin
conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and
seborrheic dermatitis. In addition, the system UVB channel is indicated for the
treatment of leukoderma.
Item 9.01 Financial Statements and Exhibits.
(a) Financial Statements of business acquired. None.
(b) Pro forma financial information. None.
(c) Shell Company Transaction. Not applicable.
(d) Exhibits. US Food & Drug Administration Letter dated July 2, 2020
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