ML 830®

Basic Information

• Brand Name: ML 830®
• Primary DI: 00859626006282
• Version / Model: ML-830-07-003
• Catalog Number: ML-830-07-003
• Company Name: MICROLIGHT CORPORATION OF AMERICA
• Labeler DUNS: 137829417
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4df379cb-ad55-4fca-92bb-4683027efa91

Device Description

SL Console

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHN	Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41176	Laser application software	An individual software program or group of programs, routines or algorithms intended to add specific computer assisted display, processing and/or analysis capabilities to a laser for storing, processing, and managing electronic information/data used during a treatment with a laser. It is typically installed in a laser and/or interfaced with an ordinary computer (e.g., tabletop, laptop) which displays the data.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859626006282	GS1

Customer Contacts

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