DEVICE: 308nm Excimer System (06971777450036)

Device Identifier (DI) Information

308nm Excimer System
XECL-308C, XECL-308D
In Commercial Distribution

Chongqing Peninsula Medical Technology Co., Ltd.
06971777450036
GS1

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545832254 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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).
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FDA Product Code

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Product Code Product Code Name
FTC Light, Ultraviolet, Dermatological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K172273 000
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Sterilization

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Sterilization Method [?]
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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Size Type Text
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Device Record Status

dbcde99c-7fd0-4e37-ac74-e8649a425841
January 21, 2019
1
December 20, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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