Refurbished GentleMax Pro 9914-58-9035

GUDID 00817495024103

Refurbished GentleMax Pro

Candela Corporation

Dermatological solid-state laser system
Primary Device ID00817495024103
NIH Device Record Key28d7112a-4129-49a3-bfe7-12c62c12f0a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameRefurbished GentleMax Pro
Version Model Number9914-58-9035
Catalog Number9914-58-9035
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495024103 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-07
Device Publish Date2022-11-29

On-Brand Devices [Refurbished GentleMax Pro]

00817495024103Refurbished GentleMax Pro
00817495024097Refurbished GentleMax Pro

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