308nm Excimer System

Basic Information

• Brand Name: 308nm Excimer System
• Primary DI: 06971777450036
• Version / Model: XECL-308C, XECL-308D
• Company Name: Chongqing Peninsula Medical Technology Co., Ltd.
• Labeler DUNS: 545832254
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-20
• Public Version: 1
• Public Version Date: 2019-01-21
• Public Version Status: New
• Public Device Record Key: dbcde99c-7fd0-4e37-ac74-e8649a425841

Device Description

308nm Excimer System is an ultratraviolet light system designed to be used in Dermatological practice for the treatment of psoriasis and vitiligo. The lamp is axenon-chloride excimer lamp which utilizes a XeCl gas mixture to generate specific ultraviolet light at wavelength of 308 nm. It displays the treatment parameters. Users can set the device and fluence on the control touch screen and determine the machine's state and function under the help of colour-coded indicator light.

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: No
• Has Manufacturing Date: No
• 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
FTC	Light, Ultraviolet, Dermatological	General, Plastic Surgery	878.4630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35149	Ultraviolet phototherapy unit, professional	A mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended to be used by a healthcare professional to treat a variety of dermatological disorders (e.g., psoriasis). The device is typically designed as a flat surface for lying with an overhead lamp(s), or as a chamber/cabinet, in which the patient stands, with interior walls lined with ultraviolet (UV) light tubes to allow full-body exposure and an even distribution of UV radiation. The device intended use may include psoralen + UVA therapy (oral administration of psoralen and subsequent exposure to UVA) (PUVA).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971777450036	GS1

Premarket Submissions

Submission Number	Supplement Number
K172273	000