TearCare(TM) System Kit 5-100

GUDID 00858027006242

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

SIGHT SCIENCES, INC.

Eyelid heat therapy system control unit
Primary Device ID00858027006242
NIH Device Record Key8cb51158-64ea-46d8-963d-28f7473bac29
Commercial Distribution StatusIn Commercial Distribution
Brand NameTearCare(TM) System Kit
Version Model NumberFG 05509
Catalog Number5-100
Company DUNS962750381
Company NameSIGHT SCIENCES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS100858027006242 [Primary]

FDA Product Code

IRTPad, Heating, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-16
Device Publish Date2018-03-16

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 Kit2022-03-11 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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