Stellar Optima Treatment Kit

Basic Information

• Brand Name: Stellar Optima Treatment Kit
• Primary DI: 07290109145129
• Version / Model: Stellar Optima Treatment Kit
• Company Name: LUMENIS LTD.
• Labeler DUNS: 600166524
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-13
• Public Version: 2
• Public Version Date: 2021-07-28
• Public Version Status: Update
• Public Device Record Key: 90e29ad9-cca0-4347-945e-9e8e72d37b75
• Distribution End Date: 2021-07-27

Device Characteristics

• Single Use: Yes
• 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: 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
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
Package	17290109145126	GS1		48	Not in Commercial Distribution	2021-07-27
Primary	07290109145129	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN200028	000