GentleYAG LE 9914-08-1020

GUDID 08174950202448

Pulsed Laser

CANDELA CORPORATION

Dermatological solid-state laser system
Primary Device ID08174950202448
NIH Device Record Key29e3fe8f-29a6-402e-aad0-17062ff153e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleYAG LE
Version Model Number9914-08-1020
Catalog Number9914-08-1020
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 110 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS108174950202448 [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 Date2016-10-03

On-Brand Devices [GentleYAG LE]

08174950202653Pulsed Laser
08174950202646Pulsed Laser
08174950202448Pulsed Laser
00817495022659Pulsed Laser
00817495022642Pulsed Laser
00817495022444Pulsed Laser

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