FDA.reportPublic FDA data

TearCare SmartLid

Primary DI
00858027006280
Brand
TearCare SmartLid
Company
Sight Sciences, Inc.
Model
FG 06113
Catalog number
5-105
Device description
Eyelid heat therapy system applicator
Published
2019-08-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858027006287PackageGS110In Commercial Distribution
00858027006280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085802700628710858027006287
00858027006280008580270062808580270062800858027006280

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid heat therapy system applicatorA skin-adherent device intended to be connected to a system control unit to deliver localized heat therapy to the outer eyelid surfaces of an adult patient during treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It consists of an adhesive heat patch/strip that is adhered to the eyelid(s), and typically a cable to allow connection to the control unit. It is intended to be used by a professional in a professional (e.g., clinical) setting. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962750381
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858027006372OMNI(R) Surgical System (US)FG 067211-1022020-06-01
00858027006549TearCare MGX System - TearCare MGX Technology KitFG 087895-1182025-04-30
00858027006297TearCare MGX System - TearCare MGX SmartLidsFG 087855-1092025-04-29
00858027006594OMNI Edge Surgical System1-1122025-03-06
00858027006358OMNI PLUS1-1042020-10-30
00858027006433OMNI Surgical SystemFG 077581-1062023-10-17
00858027006389TearCare(R) Clearance Assistant PLUSFG 069505-1072023-08-22
00858027006266TearCare(R) Clearance Assistant - SterileFG 056425-1042018-04-23
00858027006525OMNI Surgical SystemFG 074411-1082022-08-22
00858027006501Sion Surgical InstrumentFG 082551-1072022-08-01
00858027006457TearCare System - TearCare SmartHub KitFG 073925-1162022-03-03
00858027006495TearCare System - TearCare SmartLidsFG 079385-1172022-03-03
00858027006273TearCare(TM) (2.2) System KitFG 060415-1002019-08-27
10858027006256TearCare iLid (TM) Device Packaged Pair - 10 pkFG 056205-1012018-03-16
00858027006334OMNI Surgical System (US)FG 057571-1022019-10-25
00858027006013VISCO(TM)360 Viscosurgical SystemFG 039162016-09-22
00858027006112TRAB(TM)360 Trabeculotomy SystemFG 037062016-11-23
00858027006211TearCare SystemFG 050312017-02-01
00858027006228TearCare iLid PairFG 051182017-02-01
00858027006242TearCare(TM) System KitFG 055095-1002018-03-16

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