XEMIS

Basic Information

• Brand Name: XEMIS
• Primary DI: 06977593370114
• Version / Model: BL-10
• Company Name: Xemis Medical Technology (shenzhen) Co, LTD
• Labeler DUNS: 847284864
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-03
• Public Version: 1
• Public Version Date: 2025-04-11
• Public Version Status: New
• Public Device Record Key: 6a4a1da2-8596-4391-9fc1-2d649045975d

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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
47705	Cosmetic red-light phototherapy system, professional	An assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in a professional setting. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by healthcare personnel typically for patient body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06977593370114	GS1

Premarket Submissions

Submission Number	Supplement Number
K243993	000