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 |
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(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
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100 Columbia |
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Aliso Viejo, California |
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92656 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: 949 521-7830 |
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(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:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Common Stock, par value $0.001 per share |
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RXST |
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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 |
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Description |
104 |
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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.
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RxSight, Inc. |
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Date: |
July 11, 2022 |
By: |
/s/ Shelley Thunen |
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Name: Shelley Thunen |