Identity
- Trade Name
- Rosacea IV-V Filter FDA UDI
- Generic Name
- Intense pulsed light dry eye therapy unit FDA UDI
- Model / Reference
- Rosacea IV-V Filter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109144917 FDA UDI
- 510(k) Number
- DEN200028 FDA UDI
- FDA Product Code
- QIU FDA UDI
- GMDN Term
- Intense pulsed light dry eye therapy unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5201 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intense pulsed light dry eye therapy unit
Rosacea IV-V Filter by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intense pulsed light dry eye therapy unit.
- OptiLight™ Aesthetics — Lumenis Be, Inc. · Class II
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- Vanilla to OptiLight Upgrade Kit — Lumenis · Class II
Cleared under the same submission
DEN200028 also covers:
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
- Lumenis
Sources (1)
- FDA UDI 7db139ca-9332-4664-9037-78fc76eb1773 33 fields · synced May 30, 2026