Facility

SIGHT SCIENCES, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010363671
Establishment type	Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility
Location	4040 Campbell Ave. Menlo Park, CA, US 94025
Registration status	Active · expires 2026
Parent company	Sight Sciences, Inc. (owner-operator 10044440)
Brand names	TearCare System

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Eyelid Thermal Pulsation System
Product code ORZ (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.5200

Recalls & enforcement

Class IIOngoing2022-03-23
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.

FDA inspections (2)

NAI2026-05-07
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-09-12
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Sight Sciences, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SIGHT SCIENCES, INC. (FEI 3010363671) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010363671-sight-sciences-inc/

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