GMPP DCD Small Spot Option Kit, w/Fiber Assembly 7123-CE-0650

GUDID 00817495023205

CANDELA CORPORATION

Dermatological solid-state laser system
Primary Device ID00817495023205
NIH Device Record Keyb69a4bfb-3ef7-426b-bc0d-b0909e20eb3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGMPP DCD Small Spot Option Kit, w/Fiber Assembly
Version Model Number7123-CE-0650
Catalog Number7123-CE-0650
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
GS100817495023205 [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

Devices Manufactured by CANDELA CORPORATION

00817495024677 - PicoWay Laser System2024-10-21 PicoWay Laser System
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.