Skintel Melanin Reader

GUDID 00841494100605

Skintel Melanin Reader Remanufactured

Cynosure, Inc.

Multi-modality skin surface treatment system
Primary Device ID00841494100605
NIH Device Record Key0aa28223-c8b2-40a5-b844-2f62c4c9f31c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSkintel Melanin Reader
Version Model Number2520B-0038R
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
GS100841494100605 [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

On-Brand Devices [Skintel Melanin Reader]

00841494100605Skintel Melanin Reader Remanufactured
00841494100117Skintel Melanin Reader

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