Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Sight Sciences medical devices: approvals, recalls and adverse events

Stock: SGHT. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 0

PMA approvals

0 supplements

Recalled products

0 class I

Adverse event reports

130

- deaths reported

How many recalls does Sight Sciences have?

Sight Sciences has 1 recalled medical device products in 1 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Mar 23, 2022. In 2022 it had 1 recalled products.

How many medical devices has Sight Sciences had cleared or approved?

13 510(k) clearances, 0 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on Aug 18, 2026.

How many adverse event reports name Sight Sciences devices?

130 reports in total: - deaths, 82 injuries and 47 malfunctions were reported. 18 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	3	0	0	0
2025	1	0	0	0
2023	2	0	0	0
2021

Newest clearances and approvals

TearCare System
K262479 · 510(k) clearance · Aug 18, 2026
OMNI Ultra Surgical System (1-110)
K253760 · 510(k) clearance · Aug 4, 2026
TearCare MGX System
K252409 · 510(k) clearance · Apr 27, 2026
TearCare MGX System
K242786 · 510(k) clearance · Apr 15, 2025
TearCare MGX System
K231084 · 510(k) clearance · Dec 27, 2023
OMNI Surgical System
K232214 · 510(k) clearance · Aug 25, 2023
TearCare System
K213045 · 510(k) clearance · Dec 21, 2021
OMNI Surgical System
K202678 · 510(k) clearance · Mar 1, 2021
OMNI PLUS Surgical System
K201953 · 510(k) clearance · Aug 11, 2020
OMNI Surgical System
K173332 · 510(k) clearance · Dec 21, 2017
VISCO 360 Viscosurgical System
K171905 · 510(k) clearance · Jul 27, 2017
Viscoelastic Injector
K143205 · 510(k) clearance · Dec 5, 2014

Devices with the most adverse event reports

By product code, all years

Pump, Infusion, Ophthalmic (MRH, class 2)116
Trabeculotome (HMZ, class 1)10
Eyelid Thermal Pulsation System (ORZ, class 2)3
Pad, Heating, Powered (IRT, class 2)1

All device makers and procedures · SGHT stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to SGHT with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.