Diode Laser Tips

Basic Information

• Brand Name: Diode Laser Tips
• Primary DI: 00647529000366
• Version / Model: E3-7 EZ Tips
• Catalog Number: 7410002
• Company Name: Biolase, Inc.
• Labeler DUNS: 152165700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 7
• Public Version Date: 2023-06-12
• Public Version Status: Update
• Public Device Record Key: 2db71ff9-95ad-4f23-a9e5-93e617e40bff

Device Description

A single-use non-sterile fiberoptic laser tip intended for use with Biolase diode laser systems.

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: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
63476	General/multiple surgical laser system beam guide, single-use, non-sterile	A non-sterile, surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00647529002643	GS1	Boc	30	In Commercial Distribution
Primary	00647529000366	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K121286	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	300	Micrometer
Length	7	Millimeter