Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LT-300 HD

K-Number: K160380 · 2016-05-13

ApplicantLutech Industries, Inc.
Decision Date2016-05-13
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LT-300 HD is the device name listed in this FDA 510(k) record. The listed applicant is Lutech Industries, Inc.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K160380. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LT-300 HD?

LT-300 HD is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Lutech Industries, Inc.. The 510(k) number is K160380.

When did LT-300 HD receive FDA 510(k) clearance?

LT-300 HD received FDA 510(k) clearance on 2016-05-13, under 510(k) number K160380.

Who is the listed applicant for LT-300 HD?

The FDA 510(k) record lists Lutech Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LT-300 HD?

The FDA product code for LT-300 HD is HEX.

Other records listing Lutech Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170446LT-300 SD Digital Video Colposcope

Related Devices (Code: HEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233043Smart Scope® CXPeriwinkle Technologies Pvt., Ltd.K190187Gynescope SystemIllumigyn , Ltd.K182764Biop Digital ColposcopeBiop Medical , Ltd.K181034Pocket Colposcope SystemHadleigh Health Technologies, LLCK170446LT-300 SD Digital Video ColposcopeLutech Industries, Inc.K161871EVA (Enhanced Visual Assessment) SystemMobileodt , Ltd.

Official Source

View on FDA Database →

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

↑