SUPERLASER

Basic Information

• Brand Name: SUPERLASER
• Primary DI: 06973537444002
• Version / Model: SL-LC01
• Company Name: Beijing Superlaser Technology Co., Ltd.
• Labeler DUNS: 547486679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-08
• Public Version: 1
• Public Version Date: 2020-08-17
• Public Version Status: New
• Public Device Record Key: 086299aa-3348-4d05-8909-75aaff817b91

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

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
63069	General/multiple surgical diode/carbon dioxide laser system	A mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one diode mediated, and the other carbon dixoide (CO2) mediated, intended for aesthetic and tissue reconstructive applications across multiple clinical specialties (e.g., dermatological, gynaecological, urological applications) using both ablative and non-ablative lasing. It includes a laser generator with controls and a monitor.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06973537444002	GS1

Premarket Submissions

Submission Number	Supplement Number
K200042	000