Kit, PicoWay 532 HE Resolve HP

GUDID 00817495022901

Handpiece Kit

CANDELA CORPORATION

Laser skin surface treatment system applicator
Primary Device ID00817495022901
NIH Device Record Key7d9984cb-7867-477d-8e00-a13d252ffb88
Commercial Distribution StatusIn Commercial Distribution
Brand NameKit, PicoWay 532 HE Resolve HP
Version Model Number7123-00-0593
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
GS100817495022901 [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 Number2
Public Version Date2020-08-03
Device Publish Date2019-12-12

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

08174950202905Handpiece Kit
00817495022901Handpiece Kit

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