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8-K
false000111148500011114852022-07-112022-07-11

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 11, 2022

 

 

RxSight, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-40690

94-3268801

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

100 Columbia

 

Aliso Viejo, California

 

92656

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 949 521-7830

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

RXST

 

The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

 

 

Item 8.01 Other Events.

 

On June 30, 2022, RxSight, Inc. (the “Company”) received notification from the Food and Drug Administration (“FDA”) that additional information will be required for the approval of its lower-cost-to-manufacture Light Delivery Device (“LDD”). As previously disclosed, the commercial sale of the lower-cost-to manufacture LDD, which has the same functionality as the currently marketed LDD, is not planned until 2023. The Company believes it can provide the additional requested information to the FDA and obtain FDA approval without impacting its commercial introduction timeline.

 

Item 9.01 Financial Statements and Exhibits.

 

Exhibit number

 

Description

104

 

Cover Page Interactive Data File (embedded within the inline XBRL document).

 

 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

 

RxSight, Inc.

 

 

 

 

Date:

July 11, 2022

By:

/s/ Shelley Thunen

 

 

 

Name: Shelley Thunen
Title: Chief Financial Officer