Cleared Traditional

K822908 - COHERENT FUNDUSL RETINAL CAMERA

K822908 is the FDA 510(k) clearance for COHERENT FUNDUSL RETINAL CAMERA by Coherent Medical Division. It is a Class 2 Ophthalmic device (product code HKI) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K822908 · Coherent Medical Division · Ophthalmic device
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Jan 1983
Decision
97d
Days
Class 2
Risk

K822908 is an FDA 510(k) clearance for the COHERENT FUNDUSL RETINAL CAMERA. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Coherent Medical Division (Mchenry, US). The FDA issued a Cleared decision on January 5, 1983 after a review of 97 days - within the typical 510(k) review window.

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 Coherent Medical Division devices

Submission Details

510(k) Number K822908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1982
Decision Date January 05, 1983
Days to Decision 97 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 110d · This submission: 97d
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.