GentleMax Limited Edition

GUDID 08174950200413

Pulsed Laser

CANDELA CORPORATION

Dermatological solid-state laser system
Primary Device ID08174950200413
NIH Device Record Key15e6e321-b64d-417a-8a6b-09e869c34f9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleMax Limited Edition
Version Model Number9914-00-0330
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
GS108174950200413 [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 [GentleMax Limited Edition]

08174950200468Pulsed Laser
08174950200420Pulsed Laser
08174950200413Pulsed Laser
08174950200406Pulsed Laser
00817495020464Pulsed Laser
00817495020426Pulsed Laser
00817495020419Pulsed Laser
00817495020402Pulsed Laser

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