FSE, PicoWay 785nm Handpiece

GUDID 08174950202721

Handpiece Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator
Primary Device ID08174950202721
NIH Device Record Keyb115ce16-7f0a-4c43-b336-3b7389779942
Commercial Distribution StatusIn Commercial Distribution
Brand NameFSE, PicoWay 785nm Handpiece
Version Model Number7123-57-0191
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108174950202721 [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 Date2019-12-20
Device Publish Date2019-12-12

On-Brand Devices [FSE, PicoWay 785nm Handpiece]

08174950202721Handpiece Assembly
08174950227212Handpiece Assembly
00817495027210Handpiece Assembly

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