FDA.reportPublic FDA data

Nood

Primary DI
06973006910175
Brand
Nood
Company
Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd
Model
KCA423
Device description
Home-use intense pulsed light hair removal unit
Published
2022-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210119000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210119000IPL Hair Removal Device (Model: KCA423)Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.2021-05-21ONF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973006910172PackageGS120In Commercial Distribution
06973006910175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697300691017216973006910172
06973006910175069730069101756973006910175

GMDN Terms#

Term, Definition table
TermDefinition
Home-use intense pulsed light hair removal unitA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
551032473
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Company table
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08057622080028MT ONEM & T SRLONF2025-04-15
08057622080035MT ONEM & T SRLONF2025-04-15
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00850033906004XLase PlusBIOTEC ITALIA SRLONF2024-07-29
0880970938041110PLTENTECH Inc.ONF2024-06-28
0880970938043510PLTENTECH Inc.ONF2024-06-28
00850062978003WORLD AESTHETIX BROAD PULSED LIGHTWORLD AESTHETIX LLCONF2024-06-25