OMNI Surgical System

by Sight Sciences, Inc. 3 variants

510(k) K202678

OMNI Surgical System is a Class II device made by Sight Sciences, Inc., cleared under FDA 510(k) K202678 on 1 Mar 2021, active as of 10 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

510(k) K202678↗

FDA record

Trust

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK202678	Date1 Mar 2021Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K202678

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K202678
FDA product code: MRH

Device class: Class II
Regulation: 21 CFR Part 880.5725
Advisory committee: General Hospital
FDA decision: SESE Substantially Equivalent

Other devices from Sight Sciences, Inc.

OMNI Ultra Surgical System FG 09981

Class II
OMNI Ultra Surgical System (1-110)

Class II
TearCare System

Class II
OMNI Ultra Surgical System

Class IIa

See all devices from Sight Sciences, Inc. →