Refurbished Picoway 1064 Resolve Handpiece

GUDID 00817495024141

Handpiece Assembly

Candela Corporation

Dermatological laser beam producing handpiece
Primary Device ID00817495024141
NIH Device Record Keyfdda3b3b-e291-427f-b541-c3867b988320
Commercial Distribution StatusIn Commercial Distribution
Brand NameRefurbished Picoway 1064 Resolve Handpiece
Version Model Number7123-57-0059
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
GS100817495024141 [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 Date2023-03-02
Device Publish Date2023-02-22

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

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