Cleared Traditional

K170446 - LT-300 SD Digital Video Colposcope

K170446 is an FDA 510(k) clearance for LT-300 SD Digital Video Colposcope, manufactured by Lutech Industries, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K170446 · Lutech Industries, Inc. · Obstetrics & Gynecology device
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May 2017
Decision
96d
Days
Class 2
Risk

K170446 is an FDA 510(k) clearance for the LT-300 SD Digital Video Colposcope. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Lutech Industries, Inc. (Ronkonkoma, US). The FDA issued a Cleared decision on May 21, 2017 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1630 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K170446

510(k) Number K170446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2017
Decision Date May 21, 2017
Days to Decision 96 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 161d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEX Device Classification - Class 2, Special Controls

Product Code HEX Colposcope (and Colpomicroscope)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Lee & Xiao
Jimmy Wu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HEX Colposcope (and Colpomicroscope)

All 46
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K170446.
Gynescope System
K190187 · Illumigyn , Ltd. · May 2019
Biop Digital Colposcope
K182764 · Biop Medical , Ltd. · Nov 2018
Pocket Colposcope System
K181034 · Hadleigh Health Technologies, LLC · Sep 2018
EVA (Enhanced Visual Assessment) System
K161871 · Mobileodt , Ltd. · Dec 2016
Colposcope System
K160341 · Xuzhou Kernel Medical Equipment Co., Ltd. · Sep 2016
LT-300 HD
K160380 · Lutech Industries, Inc. · May 2016