Cleared Traditional

K943956 - RETINA TOMOGRAPH AND FLOWMETER

K943956 is an FDA 510(k) clearance for RETINA TOMOGRAPH AND FLOWMETER, manufactured by Heidelberg Engineering. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K943956 · Heidelberg Engineering · Ophthalmic device
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Nov 1994
Decision
91d
Days
Class 2
Risk

K943956 is an FDA 510(k) clearance for the RETINA TOMOGRAPH AND FLOWMETER. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Heidelberg Engineering (D06900 Heidelberg,Germany, DE). The FDA issued a Cleared decision on November 14, 1994 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Heidelberg Engineering devices

FDA 510(k) Submission Details - K943956

510(k) Number K943956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1994
Decision Date November 14, 1994
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLI Device Classification - Class 2, Special Controls

Product Code HLI Ophthalmoscope, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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 - HLI Ophthalmoscope, Ac-powered

All 55
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