GMPP ACC HP AIR CLIP Kit, w/o Fiber Assembly 7123-CE-0651

GUDID 00817495023212

CANDELA CORPORATION

Dermatological solid-state laser system
Primary Device ID00817495023212
NIH Device Record Key1150776f-5ddb-4f47-b037-dc06757836a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameGMPP ACC HP AIR CLIP Kit, w/o Fiber Assembly
Version Model Number7123-CE-0651
Catalog Number7123-CE-0651
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495023212 [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 Date2022-01-25
Device Publish Date2022-01-17

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