Waterlase Laser Tips

Basic Information

• Brand Name: Waterlase Laser Tips
• Primary DI: 00647529003442
• Version / Model: Side Firing Tips
• Company Name: Biolase, Inc.
• Labeler DUNS: 152165700
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-17
• Public Version: 8
• Public Version Date: 2023-06-12
• Public Version Status: Update
• Public Device Record Key: 04501d73-742f-466d-8607-3b6e9e2e3b5b
• Distribution End Date: 2017-09-30

Device Description

A reusable fiberoptic tip accessory intended for use with Waterlase laser delivery systems.

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: 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
61474	General/multiple surgical laser system beam guide, reusable	A 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; a fibreoptic cable may be included with the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00647529003459	GS1	Box	3	Not in Commercial Distribution	2017-07-13
Primary	00647529003442	GS1
Package	00647529003527	GS1	Box	1	Not in Commercial Distribution	2017-09-30
Package	00647529003510	GS1	Box	2	Not in Commercial Distribution	2017-09-30

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K161669	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	800	Micrometer
Length	18	Millimeter