Accure Laser

Powered Laser Surgical Instrument

Accure Acne, Inc.

The following data is part of a premarket notification filed by Accure Acne, Inc. with the FDA for Accure Laser.

Pre-market Notification Details

Device IDK222109
510k NumberK222109
Device Name:Accure Laser
ClassificationPowered Laser Surgical Instrument
Applicant Accure Acne, Inc. 4699 Nautilus Ct. South, Suite 205 Boulder,  CO  80301 -5307
ContactKarl Nicholls
CorrespondentKevin Walls
FDA Compliance Group 33 Golden Eagle Lane Littleton,  CO  80127
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-18
Decision Date2022-11-17

Trademark Results [Accure Laser]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCURE LASER
ACCURE LASER
88908551 not registered Live/Pending
Accure Acne, Inc
2020-05-09

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.