LightLas Pattern Scanning System - TruScan Pro

Laser, Ophthalmic

Light-Med(USA), INC.

The following data is part of a premarket notification filed by Light-med(usa), Inc. with the FDA for Lightlas Pattern Scanning System - Truscan Pro.

Pre-market Notification Details

Device IDK190448
510k NumberK190448
Device Name:LightLas Pattern Scanning System - TruScan Pro
ClassificationLaser, Ophthalmic
Applicant Light-Med(USA), INC. 1130 Calle Cordillera San Clemente,  CA  92673
ContactHedy Chiang
CorrespondentHedy Chiang
Light-Med(USA), INC. 1130 Calle Cordillera San Clemente,  CA  92673
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-25
Decision Date2019-05-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04712826771007 K190448 000
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04712826770802 K190448 000
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04712826770871 K190448 000
04712826770888 K190448 000
04712826770970 K190448 000
04712826770987 K190448 000
04712826770994 K190448 000
04712826770772 K190448 000

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