Cleared Traditional

K201552 - ApolloVue S100 Image System

K201552 is the FDA 510(k) clearance for ApolloVue S100 Image System by Apollo Medical Optics, Ltd.. It is a Class 2 General & Plastic Surgery device (product code NQQ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K201552 · Apollo Medical Optics, Ltd. · General & Plastic Surgery device
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Sep 2020
Decision
84d
Days
Class 2
Risk

K201552 is an FDA 510(k) clearance for the ApolloVue S100 Image System. Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Apollo Medical Optics, Ltd. (Taipei City, TW). The FDA issued a Cleared decision on September 2, 2020 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.1560 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Apollo Medical Optics, Ltd. devices

Submission Details

510(k) Number K201552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2020
Decision Date September 02, 2020
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQQ System, Imaging, Optical Coherence Tomography (oct)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
Definition This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Elite Biomedical Consulting, Inc.
Feng-Yu Lee

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 - NQQ System, Imaging, Optical Coherence Tomography (oct)

All 23
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K201552.
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NvisionVLE Low-profile Optical Probe
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