FDA UDI
In Commercial Distribution
🇺🇸 United States
iLux
DI: 00380650005731
·
Model: 2022
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- iLux
- Primary DI
- 00380650005731
- Version / Model
- 2022
- Catalog Number
- 8065000573
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-13
- Public Version
- 1
- Public Version Date
- 2026-03-23
- Public Version Status
- New
- Public Device Record Key
- 2042b5b2-7972-43f4-b7a7-c56dad6a0d98
Device Description
Systane iLux2 Instrument
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ORZ | Eyelid Thermal Pulsation System | Ophthalmic | 886.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58217 | Eyelid thermal pulsation system control unit | An electrically-powered ophthalmic device intended to control the application of heat and pressure (e.g., 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 applicator (not included). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380650005731 | GS1 |