Endo kit with Fixed Eye Safety Filter

Basic Information

• Brand Name: Endo kit with Fixed Eye Safety Filter
• Primary DI: 00810096330246
• Version / Model: Endo kit with Fixed ESF 532 nm
• Company Name: Lumenis Be, Inc.
• Labeler DUNS: 118292380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-02
• Public Version: 2
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: e38a693b-f50a-4e84-9920-48988ad7972d

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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36308	Operator eye protection laser filter	An eyepiece intended to be fitted to a device used during a laser procedure (e.g., surgical laser system, endoscope, surgical microscope) to protect the operator's eyes from laser energy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810096330246	GS1

Premarket Submissions

Submission Number	Supplement Number
K151109	000