Handpiece tip, reusable

GUDID 00841494100575

Cynergy PDL Handpiece tip, reusable

Cynosure, Inc.

Dermatological dye laser system
Primary Device ID00841494100575
NIH Device Record Key21da0c83-8137-46fc-9272-bfa35c396654
Commercial Distribution StatusIn Commercial Distribution
Brand NameHandpiece tip, reusable
Version Model Number100-7009-086
Company DUNS780318028
Company NameCynosure, Inc.
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 Numberfalse
Manufacturing Datefalse
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
GS100841494100575 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by Cynosure, Inc.

00841494108090 - ASSY, FOCUS ARRAY, PLATINUM, PICOSURE2022-08-16 ASSY, FOCUS ARRAY, PLATINUM, PICOSURE
00841494103507 - Vectus - Base Module Reman2022-08-15 Vectus - Base Module Reman
00841494103774 - ICON CONTROL MODULE REMAN2022-08-15 ICON CONTROL MODULE REMAN
00841494100230 - ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO3002021-08-13 ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300
00841494100537 - ASSY, FINAL LASER, PICO3002021-08-13 ASSY, FINAL LASER, PICO300
00841494100520 - ASSY, 1540 HANDPIECE, ICON2021-07-26 ASSY, 1540 HANDPIECE, ICON
00841494102272 - 1540 HANDPIECE ICON, REMANUFACTURED2021-07-26 1540 HANDPIECE ICON, REMANUFACTURED
00841494105105 - 60MM HANDPIECE W/ACC, TEMPSURE2021-07-26 60MM HANDPIECE W/ACC, TEMPSURE

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