Cleared Traditional

K161764 - SLIT LAMP, Model: YF-100

K161764 is an FDA 510(k) clearance for SLIT LAMP, manufactured by Chongqing Yeasn Science-Technology Co., Ltd.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K161764 · Chongqing Yeasn Science-Technology Co., Ltd. · Ophthalmic device
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Feb 2017
Decision
234d
Days
Class 2
Risk

K161764 is an FDA 510(k) clearance for the SLIT LAMP, Model: YF-100. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Chongqing Yeasn Science-Technology Co., Ltd. (Nan'An District, CN). The FDA issued a Cleared decision on February 16, 2017 after a review of 234 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 Chongqing Yeasn Science-Technology Co., Ltd. devices

FDA 510(k) Submission Details - K161764

510(k) Number K161764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2016
Decision Date February 16, 2017
Days to Decision 234 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 110d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJO Device Classification - Class 2, Special Controls

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 Consultant

Sgs-Ctsc Standards Technical Services Co., Ltd.
IRIS FUNG

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 - HJO Biomicroscope, Slit-lamp, Ac-powered

All 68
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