Large Sapphire Optic

GUDID 00841494100155

Vectus Large Sapphire Optic

Cynosure, Inc.

Dermatological Raman spectroscopy system
Primary Device ID00841494100155
NIH Device Record Key7d594c58-c1b4-49f7-a138-b1c0b02dcdc7
Commercial Distribution StatusIn Commercial Distribution
Brand NameLarge Sapphire Optic
Version Model Number3520C-0002
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 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
GS100841494100155 [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 Number4
Public Version Date2018-12-21
Device Publish Date2016-09-24

On-Brand Devices [Large Sapphire Optic]

00841494100162Vectus Large Sapphire Optic Refurbished
00841494100155Vectus Large Sapphire Optic

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.