Scanning System for LS-6000

Basic Information

• Brand Name: Scanning System for LS-6000
• Primary DI: B108451POSCAEL2MUS00
• Version / Model: Scanning System for LS-6000
• Company Name: BTL INDUSTRIES LIMITED
• Labeler DUNS: 733532951
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-22
• Public Version: 1
• Public Version Date: 2024-04-01
• Public Version Status: New
• Public Device Record Key: 3c7bff3c-9921-4ff1-b4ea-3b7be0b7c1a6

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: 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
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36775	Skin laser scanner	An electromechanical device intended to enable a laser beam, produced by an appropriate laser, to be scanned uniformly over a broad field of skin, typically for the removal of skin lesions (e.g., birthmarks, pigmentations) and tattoos. A laser beam is typically so intensely focused that only a tiny area can be treated at a time; large areas of skin must be treated using a scanner which sweeps the beam back and forth over the total target area.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B108451POSCAEL2MUS00	HIBCC