Bestview - The Diode Laser Machine (Model: BM-100) is - ZHENGZHOU BESTVIEW ST CO., LTD

Duns Number:421330673

Device Description: The Diode Laser Machine (Model: BM-100) is intended for hair removal, permanent hair reduc The Diode Laser Machine (Model: BM-100) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

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More Product Details

Catalog Number

-

Brand Name

Bestview

Version/Model Number

BM-100

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

K211335

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

e9cd6fc4-35ba-4836-9e1b-6bc788f60042

Public Version Date

February 01, 2022

Public Version Number

1

DI Record Publish Date

January 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZHENGZHOU BESTVIEW ST 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