Cleared Traditional

K202097 - Fundus Camera (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202097 · Huvitz Co., Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
188d
Days
Class 2
Risk

K202097 is an FDA 510(k) clearance for the Fundus Camera. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Huvitz Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on February 2, 2021 after a review of 188 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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 Huvitz Co., Ltd. devices

Submission Details

510(k) Number K202097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2020
Decision Date February 02, 2021
Days to Decision 188 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
78d slower than avg
Panel avg: 110d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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

Mtechgroup
Dave Kim

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 - HKI Camera, Ophthalmic, Ac-powered

All 155
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K202097.
Eyer 2
K251353 · Phelcom Technologies · Jan 2026
Fundus On Phone Non Mydriatic (FOP NM-10)
K252120 · Remidio Innovative Solutions Private Limited · Dec 2025
Optina-4C (MHRC-C1N)
K250770 · Optina Diagnostics, Inc. · Sep 2025
3nethra neo HD FA
K243600 · Forus Health Pvt.Ltd · Aug 2025
Resolve Fundus Camera
K250683 · Optain Health, Inc. · Apr 2025
Sentinel Camera
K243664 · Ai Optics · Dec 2024