Identity
- Trade Name
- LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE FDA UDI
- Generic Name
- Eyelid thermal pulsation system applicator, single-use FDA UDI
- Device Name
- ACTIVATORS (BOX OF 10) US FDA UDI
- Model / Reference
- LFD-2000 FDA UDI
- Description
- ACTIVATORS (BOX OF 10) US FDA UDI
Identifiers
- Catalog Number
- 221050 FDA UDI
- Primary DI / UDI-DI
- 00859623006315 FDA UDI
- FDA Product Code
- ORZ FDA UDI
- GMDN Term
- Eyelid thermal pulsation system applicator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Pressure — 6 Pound per Square Inch FDA UDI
Category: Eyelid thermal pulsation system applicator, single-use
Lipiflow System Activator Ii (disposable by Tearscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Eyelid thermal pulsation system applicator, single-use.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tearscience, Inc.
Sources (1)
- FDA UDI 09a06cf3-bc19-42bb-9c4f-7e790857caa3 37 fields · synced May 30, 2026