FDA.reportPublic FDA data

LIPIFLOW SYSTEM CONSOLE

Primary DI
00859623006414
Brand
LIPIFLOW SYSTEM CONSOLE
Company
TEARSCIENCE, INC.
Model
LFTP-1000
Catalog number
210000
Device description
ASSEMBLY PKGD LIPIFLOW - US
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORZEyelid thermal pulsation system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORZEyelid Thermal Pulsation SystemOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859623006414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859623006414008596230064148596230064140859623006414

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid thermal pulsation system control unitAn electrically-powered ophthalmic device intended to control the application of heat and pressure (intermittent pressure massage) applied to the eyelids during treatment of lid margin disease (LMD), Meibomian gland dysfunction (MGD) and/or evaporative dry eye. It typically includes controls, integrated software, and a visual display unit (VDU) and is designed to control the heat and pressure supply that are applied via an attached disposable applicator (not included).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pressure6Pound per Square Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)266-4543JJV-US-SurgicalOrders@its.jnj.com

Regulatory Flags#

DUNS number
791626901
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859623006117LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)LFD-10002210002016-09-23
00859623006315LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLELFD-20002210502016-12-24
00859623006216LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)LFD-11002210012016-09-23
00859623006018MEIBOMIAN GLAND EVALUATORMGE-10013000012018-12-20
00859623006001MEIBOMIAN GLAND EVALUATORMGE-10003000002018-12-20
20859623006135LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)LFD-10002210002016-09-23
20859623006333LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLELFD-20002210502016-12-24
00859623006513LIPIVIEW OCULAR SURFACE INTERFEROMETERLVI-10011000002016-09-23
00859623006612LIPIVIEW II OCULAR SURFACE INTERFEROMETELVI-20001001002016-09-23
00859623006711LIPIFLOW SYSTEM ACTIVATOR II CABLE KITCBL-20002401002016-12-24
00859623006919MEIBOMIAN GLAND EVALUATORDMI-10004000002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290117524077Tixel i NOVOXEL LTDORZ2026-04-06
07290117524084Tixel i HP NOVOXEL LTDORZ2026-04-06
00380650005748iLuxAlcon Laboratories, Inc.ORZ2026-03-13
00380650005731iLuxAlcon Laboratories, Inc.ORZ2026-03-13
20380650005728iLuxAlcon Laboratories, Inc.ORZ2026-03-13
00858027006549TearCare MGX System - TearCare MGX Technology KitSight Sciences, Inc.ORZ2025-04-30
00858027006297TearCare MGX System - TearCare MGX SmartLidsSight Sciences, Inc.ORZ2025-04-29
00858027006457TearCare System - TearCare SmartHub KitSight Sciences, Inc.ORZ2022-03-03
00858027006495TearCare System - TearCare SmartLidsSight Sciences, Inc.ORZ2022-03-03
00810051250022TEARSCIENCE ACTIVATOR CLEARJOHNSON & JOHNSON SURGICAL VISION, INC.ORZ2021-10-18
00810051250077TEARSCIENCE ACTIVATOR CLEARJOHNSON & JOHNSON SURGICAL VISION, INC.ORZ2021-10-18
10810051250029TEARSCIENCE ACTIVATOR CLEARJOHNSON & JOHNSON SURGICAL VISION, INC.ORZ2021-10-18
10810051250074TEARSCIENCE ACTIVATOR CLEARJOHNSON & JOHNSON SURGICAL VISION, INC.ORZ2021-10-18
00864461000401iLuxAlcon Laboratories, Inc.ORZ2018-11-05
00864461000418iLuxAlcon Laboratories, Inc.ORZ2018-11-05
00859623006315LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLETEARSCIENCE, INC.ORZ2016-12-24
20859623006333LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLETEARSCIENCE, INC.ORZ2016-12-24
00859623006711LIPIFLOW SYSTEM ACTIVATOR II CABLE KITTEARSCIENCE, INC.ORZ2016-12-24
00859623006117LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)TEARSCIENCE, INC.ORZ2016-09-23
20859623006135LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)TEARSCIENCE, INC.ORZ2016-09-23
00859623006216LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)TEARSCIENCE, INC.ORZ2016-09-23