FDA-Device2022-05-04Class II
TearCare version 1.0 SmartHubs
Sight Sciences, Inc.
Hazard
Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to distribution.
Sold states
US Nationwide distribution in the states of PA, CA, OH, AZ, CT, NC, GA, TN, MS, RI, WA, IL, FL, NV, NE, VA, SD, KY, OK, NJ, CO, TX, MI, NY, AR, WI, OR, MO, AL, NM, UT, WV, SC, IN, KS, MA, MN, NH, MT, ND, MD, WY, HI, DC, ID, LA, DE.
Affected count
921
Manufactured in
4040 Campbell Ave, Suite 100, Menlo Park, CA, United States
Products
TearCare version 1.0 SmartHubs
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1001-2022Don't want to check this manually?
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