LENSAR Laser System – Fs 3D (LLS-fs 3D)

Ophthalmic Femtosecond Laser

LENSAR, Inc.

The following data is part of a premarket notification filed by Lensar, Inc. with the FDA for Lensar Laser System – Fs 3d (lls-fs 3d).

Pre-market Notification Details

Device IDK171337
510k NumberK171337
Device Name:LENSAR Laser System – Fs 3D (LLS-fs 3D)
ClassificationOphthalmic Femtosecond Laser
Applicant LENSAR, Inc. 2800 Discovery Drive, Suite 100 Orlando,  FL  32826
ContactKeith Peck
CorrespondentKeith Peck
LENSAR, Inc. 2800 Discovery Drive, Suite 100 Orlando,  FL  32826
Product CodeOOE  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-08
Decision Date2017-08-10
Summary:summary

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