AviClear

GUDID 00816722021700

AviClear Laser System

CUTERA, INC.

Dermatological solid-state laser system
Primary Device ID00816722021700
NIH Device Record Key469f4f69-9d46-4534-bb6e-1cab1d8090aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameAviClear
Version Model NumberAviClear
Company DUNS041071643
Company NameCUTERA, 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
GS100816722021700 [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 Date2022-04-11
Device Publish Date2022-04-01

On-Brand Devices [AviClear]

00816722022707AviClear Laser Handpiece
00816722021700AviClear Laser System

Trademark Results [AviClear]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AVICLEAR
AVICLEAR
97358835 not registered Live/Pending
Cutera, Inc.
2022-04-12
AVICLEAR
AVICLEAR
90880468 not registered Live/Pending
Cutera, Inc.
2021-08-12

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