Hair Boom69, Hair Boom

GUDID 08800022304917

Low level laser therapy device.

Won Tech Co., Ltd.

Hair growth laser device
Primary Device ID08800022304917
NIH Device Record Key1bf018f3-c2bf-4f66-8547-41a2ec46941a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHair Boom69, Hair Boom
Version Model NumberHair Boom69, Hair Boom
Company DUNS688798565
Company NameWon Tech Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS108800022304917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAPLaser, Comb, Hair

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-05
Device Publish Date2019-10-28

Devices Manufactured by Won Tech Co., Ltd.

08800022305310 - The Oligio2023-02-27 Radio Frequency Therapy System
08800022305600 - PICOCAREMAJESTY2022-02-09 Q-switched Nd:YAG Laser
08800022300803 - Pastelle2021-08-24 Q-switched Nd:YAG Laser
08800022303200 - Picocare2021-08-24 Q-switched Nd:YAG Laser
08800022303217 - Picocare Family, Picocare4502021-08-24 Q-Switched Nd:YAG Laser
08800022304405 - Picowon2020-10-14 Alexandrite laser System
08800022300209 - Cosjet SR2020-02-06 Long Pulse Nd:YAG Laser
08800022304917 - Hair Boom69, Hair Boom2019-11-05Low level laser therapy device.
08800022304917 - Hair Boom69, Hair Boom2019-11-05 Low level laser therapy device.

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