CLARITY II

GUDID 08809447652696

GOGGLE 2ea

Lutronic Corporation

Dermatological solid-state laser system
Primary Device ID08809447652696
NIH Device Record Keyd1b63f20-c63d-46f9-9aa7-9f2376eea32f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLARITY II
Version Model NumberGOGGLE
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

Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809447652696 [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 Number2
Public Version Date2021-07-26
Device Publish Date2020-06-17

On-Brand Devices [CLARITY II]

08809447652474INTELLIGENT TRACKING TIP_CLARITY II (INTELLIGENT TRACKING TIP, ROLLER_MAGNET, ROLLER_SUPPORT)
08809447652467HANDPIECE ASSY_ST-A_CLARITY II_ICD (HANDPIECE_ST-A, FIBER, TIP_O_TYPE, TIP_SMALL_O_TYPE, TIP_STI
08809447654027O Type IntelliTrak tip
08809447652719CLARITY II ICD CAN ASSY 360g 1ea
08809447652696GOGGLE 2ea
08809447652689TIP_C_TYPE 5ea (Air type)
08809447652672TIP_STICK_I_TYPE 2ea
08809447652665TIP_SMALL_O_TYPE 2ea
08809447652658TIP_O_TYPE 5ea (ICD type)
08809447652610COMPL_BODY_AIR Package DI Number : 08809447652634
08809447652603HANDPIECE ASSY_ST-A_CLARITY II_AIR Package DI Number : 08809447652627
08809447652597CARTRIDGE_CLARITY II(2, 3_5, 8_10_12, 15_18_22, 16_20_24mm for USA)
08809447652573CLARITY II Series Manual for USA(Operator's Manual)
08809447652566FOOT SWITCH_CLARITY II(CLARITY II FOOT SWITCH)
08809447652559COMPL_POLE_FIBER Package DI Number:08809447652627
08809447652634COMPL_BODY_ICD
08809447652528HOLDER_WINDOW(Windoe holder)
08809447652511FUSE
08809447652504SPOT SIZE ALTERNATIVE PAPER
08809447652498Tip WINDOW

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.