SIGHT SCIENCES, INC.

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

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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

Trabeculotome (HMZ) (4) Pump, Infusion, Ophthalmic (MRH) (3) Eyelid Thermal Pulsation System (ORZ) (2) Pad, Heating, Powered (IRT) (1)

Premarket Exempt

Yes No

Clear

OMNI PLUS - 00858027006358 Catalog Number :

Device Description : OMNI PLUS Surgical System

Device Class : 1

Duns Number: 962750381

Premarket Exempt : No

Product Code : MRH, HMZ

Prescription Use : Yes

Device Count : 1

OMNI(R) Surgical System (US) - 00858027006372 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 : HMZ, MRH

Prescription Use : Yes

Device Count : 1

TearCare System - TearCare SmartHub Kit - 00858027006457 Catalog Number : 5-116

Device Description : TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter

Device Class : 2

Duns Number: 962750381

Premarket Exempt : No

Product Code : ORZ

Prescription Use : Yes

Device Count : 1

TearCare System - TearCare SmartLids - 00858027006495 Catalog Number : 5-117

Device Description : Eyelid heat therapy system applicator

Device Class : 2

Duns Number: 962750381

Premarket Exempt : No

Product Code : ORZ

Prescription Use : Yes

Device Count : 1

Sion Surgical Instrument - 00858027006501 Catalog Number : 1-107

Device Description : The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument.

Device Class : 1

Duns Number: 962750381

Premarket Exempt : Yes

Product Code : HMZ

Prescription Use : Yes

Device Count : 1

OMNI Surgical System - 00858027006525 Catalog Number : 1-108

Device Description : OMNI Surgical System: Ergo series of revisions

Device Class : 1

Duns Number: 962750381

Premarket Exempt : No

Product Code : MRH, HMZ

Prescription Use : Yes

Device Count : 1

TearCare iLid (TM) Device Packaged Pair - 10 pk - 10858027006256 Catalog Number : 5-101

Device Description : Eyelid heat therapy system applicator 10 pk

Device Class :

Duns Number: 962750381

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : Yes

Device Count : 10

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