Rosacea I-III Filter

Basic Information

• Brand Name: Rosacea I-III Filter
• Primary DI: 07290109144900
• Version / Model: Rosacea I-III Filter
• Company Name: LUMENIS LTD.
• Labeler DUNS: 600166524
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-25
• Public Version: 3
• Public Version Date: 2024-01-17
• Public Version Status: Update
• Public Device Record Key: 66a5aefe-310a-4199-a00f-7aff13a1d6ab
• Distribution End Date: 2024-01-15

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
QIU	Intense Pulsed Light Device For Managing Dry Eye	Ophthalmic	886.5201	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60386	Intense pulsed light dry eye therapy unit	A portable mains electricity (AC-powered) device intended to treat meibomian blepharitis (dry eye syndrome) by targeting the skin surrounding the meibomian glands (around the eyelid) with intense pulsed light (IPL). It consists of a generator connected to a light-emitting handpiece, and typically includes skin contact gel and light shielding safety glasses. It is intended to be operated by a healthcare professional in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290109144900	GS1