Slimlipo, 275mm Tip, EO

GUDID 00841494100483

Slimlipo, 275mm Tip, EO

Cynosure, Inc.

General/multiple surgical frequency-doubled solid-state laser system
Primary Device ID00841494100483
NIH Device Record Key4af5dcd1-7bcb-4acf-830f-17138a350771
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlimlipo, 275mm Tip, EO
Version Model Number0320-0032
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841494100483 [Primary]
GS110841494100480 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841494100483]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-20
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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