510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sight Sciences, Inc.

Menlo Park, CA, US

SIGHT SCIENCES, INC. appears in FDA device records in Menlo Park, CA. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
12
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 12 510(k) clearances for Sight Sciences, Inc. between 2013 and 2026. The busiest year on record is 2017, with 2. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Sight Sciences, Inc., by decision year
YearClearances
20131
20141
20172
20201
20212
20232
20251
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253760OMNI Ultra Surgical System (1-110)MRHSubstantially Equivalent
K252409TearCare MGX SystemORZSubstantially Equivalent
K242786TearCare MGX SystemORZSubstantially Equivalent
K231084TearCare MGX SystemORZSubstantially Equivalent
K232214OMNI Surgical SystemMRHSubstantially Equivalent
K213045TearCare SystemORZSubstantially Equivalent
K202678OMNI Surgical SystemMRHSubstantially Equivalent
K201953OMNI PLUS Surgical SystemMRHSubstantially Equivalent
K173332OMNI Surgical SystemMRHSubstantially Equivalent
K171905VISCO 360 Viscosurgical SystemMRHSubstantially Equivalent
K143205Viscoelastic InjectorMRHSubstantially Equivalent
K132494VISCOELASTIC INJECTORMRHSubstantially Equivalent

Registered establishments

FDA registered establishments for Sight Sciences, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30103636713010363671SIGHT SCIENCES, INC.4040 Campbell Ave., Menlo Park, CA 94025 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1001-2022TearCare version 1.0 SmartHubsOphthalmic 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.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain