IPL Home Use Hair Removal Device - The Device is an over-the-counter device intended - Shenzhen Beauty Every Moment intelligent electric Co.,Ltd.

Duns Number:419697777

Device Description: The Device is an over-the-counter device intended for removal of unwanted body and/or faci The Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

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More Product Details

Catalog Number

-

Brand Name

IPL Home Use Hair Removal Device

Version/Model Number

D-1130

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K211922

Product Code Details

Product Code

OHT

Product Code Name

Light Based Over-The-Counter Hair Removal

Device Record Status

Public Device Record Key

dcc636c5-e915-41cc-88a8-9852b09195b6

Public Version Date

November 10, 2021

Public Version Number

1

DI Record Publish Date

November 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHENZHEN BEAUTY EVERY MOMENT INTELLIGENT ELECTRIC 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. 21