GentleYAG

GUDID 08174950201069

Pulsed Laser

CANDELA CORPORATION

Dermatological solid-state laser system
Primary Device ID08174950201069
NIH Device Record Keyb2eb3353-5d9f-4d43-a9ea-5763fdc5fa5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleYAG
Version Model Number9914-08-0952
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
GS108174950201069 [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 ]

08174950202639Pulsed Laser
08174950202622Pulsed Laser
08174950201892Pulsed Laser
08174950201885Pulsed Laser
08174950201878Pulsed Laser
08174950201120Pulsed Laser
08174950201113Pulsed Laser
08174950201106Pulsed Laser
08174950201090Pulsed Laser
08174950201083Pulsed Laser
08174950201076Pulsed Laser
08174950201069Pulsed Laser
08174950201052Pulsed Laser
08174950200833Pulsed Laser
08174950200826Pulsed Laser
08174950200819Pulsed Laser
08174950200321Pulsed Laser
00817495020839Pulsed Laser
00817495020822Pulsed Laser
00817495020327Pulsed Laser
00817495021126Pulsed Laser
00817495021119Pulsed Laser
00817495021102Pulsed Laser
00817495021096Pulsed Laser
00817495021089Pulsed Laser
00817495021072Pulsed Laser
00817495021065Pulsed Laser
00817495021058Pulsed Laser
00817495022635Pulsed Laser
00817495022628Pulsed Laser
00817495020815Pulsed Laser
00817495021898Pulsed Laser
00817495021881Pulsed Laser
00817495021874Pulsed Laser

Trademark Results [GentleYAG]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GENTLEYAG
GENTLEYAG
76277865 2696488 Live/Registered
Candela Corporation
2001-06-28

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