SIGHT SCIENCES, INC.

Address:4040 Campbell Ave.,Menlo Park,CA,94025,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Pad, Heating, Powered (IRT) (5) Pump, Infusion, Ophthalmic (MRH) (3) Trabeculotome (HMZ) (3) Forceps, Ophthalmic (HNR) (1)

Premarket Exempt

No Yes

Clear

VISCO(TM)360 Viscosurgical System - 00858027006013 Catalog Number :

Device Description : US version of the Visco360

Device Class : 2

Duns Number: 962750381

Premarket Exempt : No

Product Code : MRH

Prescription Use : Yes

Device Count : 1

TRAB(TM)360 Trabeculotomy System - 00858027006112 Catalog Number :

Device Description : US version of the TRAB360

Device Class : 1

Duns Number: 962750381

Premarket Exempt : Yes

Product Code : HMZ

Prescription Use : Yes

Device Count : 1

TearCare System - 00858027006211 Catalog Number :

Device Description : Eyelid heat therapy system control unit

Device Class : 2

Duns Number: 962750381

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : Yes

Device Count : 1

TearCare iLid Pair - 00858027006228 Catalog Number :

Device Description : Eyelid heat therapy system applicator

Device Class :

Duns Number: 962750381

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : Yes

Device Count : 1

TearCare(TM) System Kit - 00858027006242 Catalog Number : 5-100

Device Description : TearCare System Kit including the Controller, Charging Cradle, IFU, and Charger Adapter

Device Class : 2

Duns Number: 962750381

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : Yes

Device Count : 1

TearCare(R) Clearance Assistant - Sterile - 00858027006266 Catalog Number : 5-104

Device Description : Forceps - Sterile

Device Class :

Duns Number: 962750381

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : Yes

Device Count : 1

TearCare(TM) (2.2) System Kit - 00858027006273 Catalog Number : 5-100

Device Description : TearCare System Kit including the SmartHub Controller, Charging Cradle, IFU, and

Device Class : 2

Duns Number: 962750381

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : Yes

Device Count : 1

TearCare SmartLid - 00858027006280 Catalog Number : 5-105

Device Description : Eyelid heat therapy system applicator

Device Class :

Duns Number: 962750381

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : Yes

Device Count : 1

OMNI Surgical System (US) - 00858027006310 Catalog Number : 1-100

Device Description : Omni System for US in a single pack

Device Class : 1

Duns Number: 962750381

Premarket Exempt : No

Product Code : HMZ, MRH

Prescription Use : Yes

Device Count : 1

OMNI Surgical System (US) - 00858027006334 Catalog Number : 1-102

Device Description : OMNI System for US in a single pack

Device Class : 1

Duns Number: 962750381

Premarket Exempt : No

Product Code : MRH, HMZ

Prescription Use : Yes

Device Count : 1

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