PicoLO Collimator Handpiece

GUDID 08800035501204

PicoLO Collimator Handpiece

Laseroptek Co.,Ltd

Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system
Primary Device ID08800035501204
NIH Device Record Keyf0c9879b-3617-4464-b75a-23fe432e81be
Commercial Distribution StatusIn Commercial Distribution
Brand NamePicoLO Collimator Handpiece
Version Model NumberPicoLO Collimator 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

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108800035501204 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

Devices Manufactured by Laseroptek Co.,Ltd

08800035501259 - PicoLO Body2021-05-03 PicoLO Body
08800035501181 - PicoLO Arm2021-05-03 PicoLO Arm
08800035501198 - PicoLO 532 Handpiece2021-05-03 PicoLO 532 Handpiece
08800035501204 - PicoLO Collimator Handpiece2021-05-03PicoLO Collimator Handpiece
08800035501204 - PicoLO Collimator Handpiece2021-05-03 PicoLO Collimator Handpiece
08800035501211 - PicoLO Zoom Handpiece2021-05-03 PicoLO Zoom Handpiece
08800035501228 - PicoLO 1064 Handpiece2021-05-03 PicoLO 1064 Handpiece
08800035501235 - PicoLO User Manual2021-05-03 PicoLO User Manual
08800035501242 - PicoLO Foot Switch2021-05-03 PicoLO Foot Switch

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