PROFILE BBL SYSTEM

Powered Laser Surgical Instrument

SCITON, INC.

The following data is part of a premarket notification filed by Sciton, Inc. with the FDA for Profile Bbl System.

Pre-market Notification Details

Device IDK032460
510k NumberK032460
Device Name:PROFILE BBL SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant SCITON, INC. 845 COMMERCIAL ST. Palo Alto,  CA  94303
ContactJay M Patel
CorrespondentJay M Patel
SCITON, INC. 845 COMMERCIAL ST. Palo Alto,  CA  94303
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-11
Decision Date2003-11-13
Summary:summary

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