Cleared Special

K031312 - RTA MODEL D RETINAL THICKNESS ANALYZER

K031312 is an FDA 510(k) clearance for RTA MODEL D RETINAL THICKNESS ANALYZER, manufactured by Talia Technology , Ltd.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Special 510(k) pathway after a 12-day FDA review.

K031312 · Talia Technology , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
12d
Days
Class 2
Risk

K031312 is an FDA 510(k) clearance for the RTA MODEL D RETINAL THICKNESS ANALYZER. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Talia Technology , Ltd. (Washington, US). The FDA issued a Cleared decision on May 6, 2003 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Talia Technology , Ltd. devices

FDA 510(k) Submission Details - K031312

510(k) Number K031312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2003
Decision Date May 06, 2003
Days to Decision 12 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 110d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 60
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