UltraSlim Digital, UltraSmooth Digital

Fat Reducing Low Level Laser

Ward Photonics LLC

The following data is part of a premarket notification filed by Ward Photonics Llc with the FDA for Ultraslim Digital, Ultrasmooth Digital.

Pre-market Notification Details

Device IDK202361
510k NumberK202361
Device Name:UltraSlim Digital, UltraSmooth Digital
ClassificationFat Reducing Low Level Laser
Applicant Ward Photonics LLC 1980 N Atlantic Avenue Cocoa Beach,  FL  32931
ContactTerry Ward
CorrespondentJeff Brown
Jeff Brown Lifescience 1260 Bell View Circle Sandy,  UT  84094
Product CodeOLI  
CFR Regulation Number878.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-19
Decision Date2020-12-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860925000345 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000345 K202361 000
00860925000338 K202361 000
00860925000338 K202361 000

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.