Kit, PicoWay 532nm Resolve Fusion HP

GUDID 00817495022925

Handpiece Kit

CANDELA CORPORATION

Laser skin surface treatment system applicator
Primary Device ID00817495022925
NIH Device Record Keyb9c2552e-ee42-4f8a-96e5-d29ea5551b6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameKit, PicoWay 532nm Resolve Fusion HP
Version Model Number7123-00-0595
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 Kittrue
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

Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com
Phone800-733-8550
Emailcustomer.service@candelamedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495022925 [Primary]
GS108174950202929 [Previous]

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 Number2
Public Version Date2020-08-03
Device Publish Date2019-12-12

On-Brand Devices [Kit, PicoWay 532nm Resolve Fusion HP]

08174950202929Handpiece Kit
00817495022925Handpiece Kit

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