Picocare Family, Picocare450

GUDID 08800022303217

Q-Switched Nd:YAG Laser

Won Tech Co., Ltd.

Dermatological frequency-doubled solid-state laser system
Primary Device ID08800022303217
NIH Device Record Key20859f0d-55f2-4600-8439-126473763ff1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePicocare Family, Picocare450
Version Model NumberPicocare Family, Picocare450
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800022303217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-08-24
Device Publish Date2020-06-16

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, Picocare4502021-08-24Q-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 Boom2019-11-05 Low level laser therapy device.

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