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510(k) K202927

EYE-SYNC by Syncthink, Inc. — Product Code QEA

K202927 is an FDA 510(k) premarket notification submitted by Syncthink, Inc. for the device "EYE-SYNC". The FDA issued a decision of Substantially Equivalent on October 2, 2021. The device falls under product code QEA (Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid), a Class II device regulated under 21 CFR 882.1455. Syncthink, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2021
Date Received
September 29, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Device Class
Class II
Regulation Number
882.1455
Review Panel
NE
Submission Type

A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.

Other clearances by Syncthink, Inc.

  • K152915 — EYE-SYNC (January 29, 2016)

Other clearances for product code QEA

  • K254086 — EyeBOX SNAP (June 5, 2026)
  • K242116 — EyeBOX EBX-4.1 (April 4, 2025)
  • K212310 — EyeBOX (Model EBX-4) (December 22, 2021)
  • K201841 — EyeBOX (September 6, 2020)
  • K191183 — EyeBOX (July 31, 2019)
  • DEN170091 — EyeBOX (December 28, 2018)

FDA data resources