PicoWay 532nm Resolve Fusion Handpiece

GUDID 00817495022864

Handpiece Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece
Primary Device ID00817495022864
NIH Device Record Key5761c897-36f3-40fd-a079-c807a9fe04ce
Commercial Distribution StatusIn Commercial Distribution
Brand NamePicoWay 532nm Resolve Fusion Handpiece
Version Model Number7123-00-0536
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

Phone800-733-8550
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
GS100817495022864 [Primary]
GS108174950202868 [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 [PicoWay 532nm Resolve Fusion Handpiece]

08174950202868Handpiece Assembly
00817495022864Handpiece Assembly

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.