Tip, Spacer, Dye Handpiece

GUDID 00841494107970

Tip, Spacer, Dye Handpiece

Cynosure, Inc.

Light-energy skin surface treatment system applicator
Primary Device ID00841494107970
NIH Device Record Keycd9390be-ce95-4bb5-9bca-a32cde23bdf1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTip, Spacer, Dye Handpiece
Version Model Number130-7017-015
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
GS100841494107970 [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 Date2018-09-14
Device Publish Date2018-08-14

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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