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FDA 510(k)

LightLas Pattern Scanning System - TruScan Pro

K-Number: K190448 · 2019-05-24

ApplicantLight-Med(Usa), Inc.
Decision Date2019-05-24
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LightLas Pattern Scanning System - TruScan Pro is the device name listed in this FDA 510(k) record. The listed applicant is Light-Med(Usa), Inc.. It received FDA 510(k) clearance on 2019-05-24 under 510(k) number K190448. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LightLas Pattern Scanning System - TruScan Pro?

LightLas Pattern Scanning System - TruScan Pro is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Light-Med(Usa), Inc.. The 510(k) number is K190448.

When did LightLas Pattern Scanning System - TruScan Pro receive FDA 510(k) clearance?

LightLas Pattern Scanning System - TruScan Pro received FDA 510(k) clearance on 2019-05-24, under 510(k) number K190448.

Who is the listed applicant for LightLas Pattern Scanning System - TruScan Pro?

The FDA 510(k) record lists Light-Med(Usa), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LightLas Pattern Scanning System - TruScan Pro?

The FDA product code for LightLas Pattern Scanning System - TruScan Pro is HQF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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