Cleared Traditional

K162778 - Portable Slit Lamp Microscope

K162778 is the FDA 510(k) clearance for Portable Slit Lamp Microscope by Suzhou Kangjie Medical, Inc.. It is a Class 2 Ophthalmic device (product code HJO) cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K162778 · Suzhou Kangjie Medical, Inc. · Ophthalmic device
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Jul 2017
Decision
294d
Days
Class 2
Risk

K162778 is an FDA 510(k) clearance for the Portable Slit Lamp Microscope. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Suzhou Kangjie Medical, Inc. (Suzhou, CN). The FDA issued a Cleared decision on July 21, 2017 after a review of 294 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Suzhou Kangjie Medical, Inc. devices

Submission Details

510(k) Number K162778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date July 21, 2017
Days to Decision 294 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 110d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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 Ophthalmic devices follow this clearance model.

Regulatory Peers - HJO Biomicroscope, Slit-lamp, Ac-powered

All 26
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K162778.
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