SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNER

Powered Laser Surgical Instrument

SHARPLAN LASERS, INC.

The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan Lasers, Inc Silktouch 2 Flash Scanner.

Pre-market Notification Details

Device IDK955621
510k NumberK955621
Device Name:SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNER
ClassificationPowered Laser Surgical Instrument
Applicant SHARPLAN LASERS, INC. ONE PEARL CT. Allendale,  NJ  07401
ContactGeorge J Hattub
CorrespondentGeorge J Hattub
SHARPLAN LASERS, INC. ONE PEARL CT. Allendale,  NJ  07401
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-11
Decision Date1996-02-27

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