Vbeam

GUDID 08174950200314

Pulsed Laser

CANDELA CORPORATION

Dermatological dye laser system
Primary Device ID08174950200314
NIH Device Record Key5b91363e-6cdd-49be-ae86-5f03f64416e6
Commercial Distribution Discontinuation2020-06-29
Commercial Distribution StatusNot in Commercial Distribution
Brand NameVbeam
Version Model Number9914-08-0723
Company DUNS053468385
Company NameCANDELA 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108174950200314 [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 Date2020-06-30
Device Publish Date2016-09-23

On-Brand Devices [Vbeam ]

08174950201373Pulsed Laser
08174950200314Pulsed Laser
08174950200307Pulsed Laser
00817495021584Pulsed Laser
00817495020433Pulsed Laser

Trademark Results [Vbeam]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VBEAM
VBEAM
75893036 2515791 Live/Registered
Candela Corporation
2000-01-10

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