GentleLase Pro Limited Edition 

GUDID 08174950201007

Pulsed Laser

CANDELA CORPORATION

Dermatological solid-state laser system
Primary Device ID08174950201007
NIH Device Record Keyd5cb074c-1e8b-4630-bc63-db986d674637
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleLase Pro Limited Edition 
Version Model Number9914-16-9040
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
GS108174950201007 [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 [GentleLase Pro Limited Edition ]

08174950201007Pulsed Laser
08174950200994Pulsed Laser

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