Aymo - IPL HAIR REMOVAL DEVICE - Medical Device Branch of Zhangzhou Easepal Industrial Corporation

Duns Number:554415413

Device Description: IPL HAIR REMOVAL DEVICE

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More Product Details

Catalog Number

-

Brand Name

Aymo

Version/Model Number

Aymo Beauty D50 148Q-BD50XX-USDG0A

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

-

Product Code Details

Product Code

OHT

Product Code Name

Light Based Over-The-Counter Hair Removal

Device Record Status

Public Device Record Key

229ba507-c012-4ef4-affa-8ad16065d552

Public Version Date

May 28, 2021

Public Version Number

1

DI Record Publish Date

May 20, 2021

Additional Identifiers

Package DI Number

16973504240016

Quantity per Package

10

Contains DI Package

06973504240019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDICAL DEVICE BRANCH OF ZHANGZHOU EASEPAL INDUSTRIAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2