GentleYAG12MM Fiber Assembly 7122-00-3122

GUDID 08174950202493

Fiber Assembly

CANDELA CORPORATION

Dermatological solid-state laser system
Primary Device ID08174950202493
NIH Device Record Key5957b56b-fd6d-4d33-9025-720ca6440cdf
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleYAG12MM Fiber Assembly
Version Model Number7122-00-3122
Catalog Number7122-00-3122
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
GS108174950202493 [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 Date2020-02-06
Device Publish Date2016-10-03

On-Brand Devices [GentleYAG12MM Fiber Assembly]

08174950202493Fiber Assembly
00817495022499Fiber Assembly

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