DeepFX Air Disposable Tips

Basic Information

• Brand Name: DeepFX Air Disposable Tips
• Primary DI: 17290117771836
• Version / Model: NA
• Company Name: LUMENIS BE LTD
• Labeler DUNS: 600763501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2023-12-04
• Public Version: 2
• Public Version Date: 2023-12-25
• Public Version Status: Update
• Public Device Record Key: d64fc67f-4073-4c00-868c-109fcd676fbf

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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64016	Laser beam-guide spacer	A non-sterile device designed to fit over the distal end of a non-surgically-invasive laser applicator/beam-guide to function as a spacer to ensure correct distance is maintained between the laser applicator/beam-guide and tissues during laser surgery. It is typically a small plastic cap-like device, which may also be intended to function as a cover to avoid cross-contamination between patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07290117771839	GS1
Primary	17290117771836	GS1

Premarket Submissions

Submission Number	Supplement Number
K212703	000
K233301	000