Accu-Beam

Basic Information

• Brand Name: Accu-Beam
• Primary DI: B17761090
• Version / Model: 6109
• Company Name: TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
• Labeler DUNS: 130213366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-11
• Public Version: 1
• Public Version Date: 2024-11-19
• Public Version Status: New
• Public Device Record Key: 99c58cf5-b1a6-41ec-bd8b-666ac39043a1

Device Description

Collimated CO2 Laser Handpiece.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
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	B17761090	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K945648	000