Cleared Special

K061674 - RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER

K061674 is an FDA 510(k) clearance for RTA 5 & RTA MODEL E RETINAL THICKNESS A..., 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 70-day FDA review.

K061674 · Talia Technology , Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
70d
Days
Class 2
Risk

K061674 is an FDA 510(k) clearance for the RTA 5 & RTA MODEL E 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 August 23, 2006 after a review of 70 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.

FDA 510(k) Submission Details - K061674

510(k) Number K061674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2006
Decision Date August 23, 2006
Days to Decision 70 days
Submission Type Special
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
40d faster than avg
Panel avg: 110d · This submission: 70d
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 84
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K061674 · RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER
Download PDF FDA Summary Talia Technology , Lt…