ASSY, DELIVERY SYS, DCD HP, PRIMA REFURBISHED

GUDID 00817495024585

ASSY, DELIVERY SYS, DCD HP, PRIMA REFURBISHED

Candela Corporation

Dermatological laser beam producing handpiece
Primary Device ID00817495024585
NIH Device Record Keyb7dbb7f1-f37b-4f97-b0df-a52739af4327
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSY, DELIVERY SYS, DCD HP, PRIMA REFURBISHED
Version Model Number7123-57-0433
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
GS100817495024585 [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 Date2023-05-09
Device Publish Date2023-05-01

Devices Manufactured by Candela Corporation

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00817495023540 - PicoWay Laser System2024-10-14 Picoway Laser System
00817495023663 - PicoWay Laser System2024-10-14 Picoway Laser System
00817495023588 - PicoWay Laser System2024-10-08 Picoway Laser System
00817495024639 - GYAG Pro U Laser System2024-10-02 GYAG Pro U Laser System
00817495024646 - Glase Pro U Laser System2024-10-02 Glase Pro U Laser System
00817495024653 - GMAX Pro Laser System2024-10-02 GMAX Pro Laser System
00817495024660 - GMAX Pro Plus Laser System2024-10-02 GMAX Pro Plus Laser System

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