CLARITY

GUDID 8809447651415

CLARITY-LPC, ICD 1.5 body (CLARITY LPC Laser System)

Lutronic Corporation

Dermatological solid-state laser system
Primary Device ID8809447651415
NIH Device Record Key23aaba21-6d21-4613-b47e-2a125bc4cda7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLARITY
Version Model NumberCLARITY-LPC, ICD 1.5 body
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 Numbertrue
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
Phone215-205-2219
Emailjvojir@lutronic.com

Operating and Storage Conditions

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
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
GS108809447651408 [Primary]
GS18809447651415 [Package]
Contains: 08809447651408
Package: Wooden case [1 Units]
In Commercial Distribution

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 Date2016-09-09

Devices Manufactured by Lutronic Corporation

08809447652191 - N/A2023-06-19 Metal Goggle (for patient) of Advantage/Eco2/ACTIONII/SPECTRA/CLARITY/ LASEMD/ DENTAII / PICOPLUS
08809447655239 - DermaV2022-03-07 CARTRIDGE_DermaV_2, 3, 5_7, 8_10_12, 12_14_16, 3X10 mm, FRACTIONAL
08809447655246 - DermaV2022-03-07 HANDPIECE ASSY_ST-A_GL19
08809447655253 - DermaV2022-03-07 COMPL_POLE_FIBER
08809447655260 - DermaV2022-03-07 WINDOW HOLDER ASSY_GL19
08809447655277 - DermaV2022-03-07 COMPL_BODY_ICD_S_DermaV_220V / USA / ICD
08809447655284 - DermaV2022-03-07 FOOT SWITCH_GL19
08809447655291 - DermaV2022-03-07 DermaV_MANUAL_REV00_USA

Trademark Results [CLARITY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLARITY
CLARITY
98794066 not registered Live/Pending
Solventum Intellectual Properties Company
2024-10-10
CLARITY
CLARITY
98718262 not registered Live/Pending
Groben, Mason C.
2024-08-26
CLARITY
CLARITY
98647012 not registered Live/Pending
Clarity Movement Co.
2024-07-13
CLARITY
CLARITY
98641763 not registered Live/Pending
Clarity Pharmaceuticals Ltd
2024-07-10
CLARITY
CLARITY
98519512 not registered Live/Pending
Solventum Intellectual Properties Company
2024-04-25
CLARITY
CLARITY
98449573 not registered Live/Pending
A & A Drug Co.
2024-03-14
CLARITY
CLARITY
98405327 not registered Live/Pending
Pitney Bowes Inc.
2024-02-14
CLARITY
CLARITY
98352796 not registered Live/Pending
Precision Planting LLC
2024-01-11
CLARITY
CLARITY
98260471 not registered Live/Pending
Quorum Cyber Security Limited
2023-11-08
CLARITY
CLARITY
98260047 not registered Live/Pending
Fuelling, Adam D
2023-11-08
CLARITY
CLARITY
98258687 not registered Live/Pending
Magi, Inc.
2023-11-07
CLARITY
CLARITY
98258327 not registered Live/Pending
Ceribell, Inc.
2023-11-07

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