TrueSpot™ 2.0mm Handpiece

Basic Information

• Brand Name: TrueSpot™ 2.0mm Handpiece
• Primary DI: 07290117771679
• Version / Model: NA
• Company Name: LUMENIS BE LTD
• Labeler DUNS: 600763501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-04
• Public Version: 1
• Public Version Date: 2023-12-12
• Public Version Status: New
• Public Device Record Key: a2cdc8d0-92c9-4778-8abf-8cc3239d5bfb

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: 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
63306	Surgical laser system beam-focus handpiece	A noninvasive hand-held device intended to be connected to the beam guide of a surgical laser system to focus the laser beam during delivery to the target tissue. It is in the form of a rigid cylinder with integrated lenses which focus laser beam wavelengths for surgical applications. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290117771679	GS1
Direct Marking	07290117772140	GS1

Premarket Submissions

Submission Number	Supplement Number
K030147	000