N/A

GUDID 08809447650517

Spectra 3-8 ZOOM COLLIMATED HP (20%UP) (8mm-Zoom-collimated handpiece)

Lutronic Corporation

General/multiple surgical frequency-doubled solid-state laser system
Primary Device ID08809447650517
NIH Device Record Key1c0241f0-5b4f-48f9-ae05-04130d0e30b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number3-8 ZOOM COLLIMATED HP (20%UP)
Company DUNS688282516
Company NameLutronic Corporation
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone215-205-2219
Emailjvojir@lutronic.com
Phone215-205-2219
Emailjvojir@lutronic.com
Phone215-205-2219
Emailjvojir@lutronic.com
Phone215-205-2219
Emailjvojir@lutronic.com
Phone215-205-2219
Emailjvojir@lutronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108809447650517 [Primary]

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 Date2021-07-26
Device Publish Date2016-07-27

On-Brand Devices [N/A]

08809447652184Operator's Goggle for CLARITY/ADVANTAGE
08809447652160Operator's Goggle for LASEMD/ACTION II
08809447652009LASEMD Operator's Manual for USA
08809447651996BLISTERED COMB SET
08809447651989BLISTERED SQUARE SET
08809447651972BLISTERED ROLLER SET
08809447651491Clarity Foot Switch Assy (Foot Switch)
08809447651484Clairty Operator's Manual (Operator's manual)
8809447651477CLARITY ICD CAN ASSY 780g (ICD Canister)
08809447651453Clarity Hybrid Cooling Set (Hybrid Air Cooling Clip)
08809447651446Clarity ICD CARTRIDGE SET
8809447651439CLARITY HANDPIECE+FIBER ASSY (Optical fiber with handpiece)
8809447651767CLARITY ICD CAN ASSY 360g (ICD Canister)
08809447652436Spectra Lotion for KSA (Kingdom of Saudi Arabia)
08809447652139Patient Goggle for INFINI
08809447652122Goggle ASSY (For patient) of HEALITE II / Rubber goggle
08809447652115PICOPLUS ARM
08809447652061PICOPLUS Operator's Manual (ENG, US)
08809447652054Pico Toning Collimated Handpiece (6-10mm)
08809447652047Zoom Handpiece (1-6mm)
08809447651941Action II TIP 9x9 (Fractional TIP)
08809447651934ACTIONII Operator's Manual for USA
08809447651927Petit 360 Handpiece
08809447651910PETIT 90 Handpiece
08809447651903Shiningpeel Handpiece
08809447651897Array Handpiece (Fractional Handpiece)
08809447651880Action II 1-7mm Zoom Handpiece (Zoom Handpiece)
08809447651866ActionII ARM (Articulated ARM)
8809447651774INFINI MFR TIP A-49 1 ea(MFR 49 Tip)
8809447651736Healite II Arm (Arn)
08809447651712Healite II Manual (Operator's Manual)
8809447651682Healite II 830&590nm Head (830/590nm head)
08809447651668eCO2 Foot Switch (Foot Switch)
08809447651651eCO2 Manual (Operator's Manual)
08809447651644eCO2 SPⅢ ZOOM Handpiece Set (Zoom Handpiece)
08809447651637eCO2 SPⅢ Micro Handpiece Set (F50 Handpiece)
08809447651620eCO2 SPⅢ Handpiece Set (F100 Handpiece)
8809447651613eCO2 PLUS(USA) ARM (Articulated Arm)
8809447651392ADVANTAGE ASSY HANDPIECE 10x10mm BAHR1060 (ADVANTAGE D1-1064 handpiece)
08809447651378ADVANTAGE Cooling gel (Coupling Gel)
08809447651361Advantage Operator’s Manual (Operator's Manual)
8809447651354ADVANTAGE ASSY HANDPIECE 10x30mm BAHR800 (ADVANTAGE D3-800 handpiece)
8809447651330ADVANTAGE ASSY HANDPIECE 10x10mm SAHR800 (ADVANTAGE D1-800 handpiece)
08809447651316ADVANTAGE Assy Foot switch (optional) (Footswitch)
8809447651309Advantage CART ASSY (Cart)
08809447651187AC POWER CABLE 3M (eCO2, INFINI, Healite II, ADVANTAGE etc)
08809447651170INFINI Operator's Manual USA (Operator's Manual)
08809447651064INFINI TIP A-16 1 ea (MFR 16 Tip)
08809447651033INFINI MFR 49 TIP II 1 ea(MFR 49 Tip)
8809447651026INFINI Handpiece cradle stand assy (Handpiece cradle)
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