308nm Excimer System - 308nm Excimer System is an ultratraviolet light - Chongqing Peninsula Medical Technology Co., Ltd.

Duns Number:545832254

Device Description: 308nm Excimer System is an ultratraviolet light system designed to be used in Dermatologic 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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More Product Details

Catalog Number

-

Brand Name

308nm Excimer System

Version/Model Number

XECL-308C, XECL-308D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172273

Product Code Details

Product Code

FTC

Product Code Name

Light, Ultraviolet, Dermatological

Device Record Status

Public Device Record Key

dbcde99c-7fd0-4e37-ac74-e8649a425841

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHONGQING PENINSULA MEDICAL TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2