GentleYAG Pro-U

GUDID 08174950200901

Pulsed Laser

CANDELA CORPORATION

Dermatological solid-state laser system
Primary Device ID08174950200901
NIH Device Record Key69304ba1-63aa-4e66-84d3-c6f3315b03c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleYAG Pro-U
Version Model Number9914-15-9020
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

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108174950200901 [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 Date2020-02-06
Device Publish Date2016-09-23

On-Brand Devices [GentleYAG Pro-U]

08174950200918Pulsed Laser
08174950200901Pulsed Laser
08174950200895Pulsed Laser
00817495020914Pulsed Laser
00817495020907Pulsed Laser
00817495020891Pulsed Laser

Trademark Results [GentleYAG Pro-U]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GENTLEYAG PRO-U
GENTLEYAG PRO-U
85872074 4453829 Live/Registered
Candela Corporation
2013-03-10

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