DEVICE: IPL Home Use Hair Removal Device (06974879933865)

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Device Record History
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Device Identifier (DI) Information
IPL Home Use Hair Removal Device
D-1186
In Commercial Distribution

Shenzhen Beauty Every Moment intelligent electric Co.,Ltd.
06974879933865
GS1

1
419697777 *Terms of Use
IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
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GMDN

[?]

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?
65776 Home-use intense pulsed light hair removal unit
A hand-held, electrically-powered device designed to be used in the home to produce strong, controlled flashes of filtered light in the wavelength range of 400 - 1200nm [intense pulsed light (IPL)] for self-removal of unwanted hair.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OHT Light Based Over-The-Counter Hair Removal
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K221001 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
1c631921-7e93-4938-992a-c4152e96db04
July 10, 2024
1
July 02, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
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Customer Contact

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No Customer Contact currently defined
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