HYPERION Blue Handpiece

GUDID 08800035500450

HYPERION Blue Handpiece

Laseroptek Co.,Ltd

Dermatological solid-state laser system
Primary Device ID08800035500450
NIH Device Record Key6565765a-f6dc-4f83-b080-641342634904
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYPERION Blue Handpiece
Version Model NumberHYPERION Blue Handpiece
Company DUNS689856875
Company NameLaseroptek 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

Operating and Storage Conditions

Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108800035500450 [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 Number4
Public Version Date2020-02-06
Device Publish Date2018-01-12

Devices Manufactured by Laseroptek Co.,Ltd

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08800035501792 - PALLAS Premium Handpiece - 15 x 152023-02-16 PALLAS Premium Handpiece - 15 x 15
08800035501808 - PALLAS Premium Handpiece - 18 x 182023-02-16 PALLAS Premium Handpiece - 18 x 18
08800035501815 - PALLAS Premium Foot Switch2023-02-16 PALLAS Premium Foot Switch
08800035501822 - PALLAS Premium User Manual2023-02-16 PALLAS Premium User Manual
08800035501730 - HELIOS 785 Pico Body2023-01-13 HELIOS 785 Pico Body

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