Item 7.01. Regulation FD Disclosure
On February 1, 2021, Soliton, Inc. (the "Company") issued a press release
announcing that the U.S. Food & Drug Administration has cleared its Rapid
Acoustic Pulse ("RAP") technology for the short-term improvement in the
appearance of cellulite. The clearance was received on January 29, 2021. The
device is indicated for use as an accessory to the 1064 nm Q-Switched laser for
black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The RAP device
is also indicated for short-term improvement in the appearance of cellulite. A
copy of the press release is attached to this report as Exhibit 99.1 and is
incorporated by reference herein.
The information contained in Item 7.01 of this Current Report on Form 8-K,
including Exhibit 99.1, is being furnished and shall not be deemed to be "filed"
for the purpose of the Securities Exchange Act of 1934, as amended ("Exchange
Act"), nor shall it be deemed incorporated by reference in any filing under the
Exchange Act or the Securities Act of 1933, as amended, unless specifically
identified therein as being incorporated by reference.
Item 8.01. Other Events
On January 29, 2021, the U.S. Food & Drug Administration cleared the Company's
Rapid Acoustic Pulse ("RAP") technology for the short-term improvement in the
appearance of cellulite. The device is indicated for use as an accessory to the
1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type
I-III patients. The RAP device is also indicated for short-term improvement in
the appearance of cellulite. In the clinical trials submitted to the FDA as part
of the 510(k) application that was cleared, patient results were generated by a
single, non-invasive treatment that required no anesthesia, caused no unexpected
or serious adverse events, received strong patient satisfaction ratings and was
well tolerated by the trial subjects, with an average pain score of 2.4 out of
10. The RAP device induces mechanical disruption in fibrous structures, such as
the septae contributing to dimples in cellulite, that results in release of the
dimples and general smoothing of the skin.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
Exhibit
No. Exhibit
99.1 Soliton, Inc. press release dated February 1, 2021
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SOLITON, INC. 
