LUCENTLITE, MODEL IMD 010

Powered Laser Surgical Instrument

INDUSTRIAL & MEDICAL DESIGN, INC.

The following data is part of a premarket notification filed by Industrial & Medical Design, Inc. with the FDA for Lucentlite, Model Imd 010.

Pre-market Notification Details

Device IDK033072
510k NumberK033072
Device Name:LUCENTLITE, MODEL IMD 010
ClassificationPowered Laser Surgical Instrument
Applicant INDUSTRIAL & MEDICAL DESIGN, INC. 2570 CORPORATE PL., SUITE E104 Monterey Park,  CA  91754
ContactYevgeniy Kuklin
CorrespondentYevgeniy Kuklin
INDUSTRIAL & MEDICAL DESIGN, INC. 2570 CORPORATE PL., SUITE E104 Monterey Park,  CA  91754
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-29
Decision Date2004-04-01
Summary:summary

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