PROFILE MULTI-PLATFORM 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 Multi-platform System.

Pre-market Notification Details

Device IDK060033
510k NumberK060033
Device Name:PROFILE MULTI-PLATFORM SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant SCITON, INC. 925 COMMERCIAL ST. Palo Alto,  CA  94303
ContactJay M Patel
CorrespondentJay M Patel
SCITON, INC. 925 COMMERCIAL ST. Palo Alto,  CA  94303
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-05
Decision Date2006-02-28
Summary:summary

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