Cbeam 7MM Handpiece Assembly

GUDID 08174950202226

Handpiece Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator
Primary Device ID08174950202226
NIH Device Record Key7d6a5b70-6617-4dfe-a518-62189f58cd8f
Commercial Distribution Discontinuation2020-06-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCbeam 7MM Handpiece Assembly
Version Model Number7122-00-3151
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108174950202226 [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 Number4
Public Version Date2020-07-01
Device Publish Date2016-09-23

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