TearCare System - TearCare SmartHub Kit 5-116

GUDID 00858027006457

TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter

SIGHT SCIENCES, INC.

Eyelid heat therapy system control unit
Primary Device ID00858027006457
NIH Device Record Key1a811121-a176-44b8-b119-458e532da73a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTearCare System - TearCare SmartHub Kit
Version Model NumberFG 07392
Catalog Number5-116
Company DUNS962750381
Company NameSIGHT SCIENCES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858027006457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORZEyelid Thermal Pulsation System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-11
Device Publish Date2022-03-03

Devices Manufactured by SIGHT SCIENCES, INC.

00858027006433 - OMNI Surgical System2023-10-25 OMNI Surgical System, 21 uL
00858027006389 - TearCare(R) Clearance Assistant PLUS2023-08-30 TearCare Clearance Assistant PLUS
00858027006280 - TearCare SmartLid 2023-08-22 Eyelid heat therapy system applicator
00858027006266 - TearCare(R) Clearance Assistant - Sterile2023-08-04 Forceps - Sterile
00858027006525 - OMNI Surgical System2022-08-30 OMNI Surgical System: Ergo series of revisions
00858027006501 - Sion Surgical Instrument2022-08-09 The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument.
00858027006457 - TearCare System - TearCare SmartHub Kit2022-03-11TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter
00858027006457 - TearCare System - TearCare SmartHub Kit2022-03-11 TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter
00858027006495 - TearCare System - TearCare SmartLids2022-03-11 Eyelid heat therapy system applicator

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