PicoWay Zoom Handpiece Kit

GUDID 08174950203100

Handpiece Kit

CANDELA CORPORATION

Laser skin surface treatment system applicator
Primary Device ID08174950203100
NIH Device Record Key2dd69de3-2e59-42f0-a745-76534e786aa0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePicoWay Zoom Handpiece Kit
Version Model Number7123-00-0637
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108174950203100 [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 Date2020-01-13
Device Publish Date2020-01-03

On-Brand Devices [PicoWay Zoom Handpiece Kit]

08174950203100Handpiece Kit
00817495023106Handpiece Kit

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