Cleared Traditional

K142953 - OCT-Camera

K142953 is the FDA 510(k) clearance for OCT-Camera by Optomedical Technologies GmbH. It is a Class 2 Ophthalmic device (product code HLI) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K142953 · Optomedical Technologies GmbH · Ophthalmic device
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Mar 2015
Decision
145d
Days
Class 2
Risk

K142953 is an FDA 510(k) clearance for the OCT-Camera. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Optomedical Technologies GmbH (Luebeck, DE). The FDA issued a Cleared decision on March 4, 2015 after a review of 145 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 Optomedical Technologies GmbH devices

Submission Details

510(k) Number K142953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2014
Decision Date March 04, 2015
Days to Decision 145 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 110d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 21
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K142953.
VANTAGE INDIRECT OPHTHALMOSCOPE
K060822 · Keeler Instruments, Inc. · May 2006
WELCH ALLYN 11800 OPTHALMOSCOPE
K003376 · Welch Allyn, Inc. · Jan 2001
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
K992606 · Canon USA, Inc. · Jun 2000
HUMPHREY OCT SCANNER
K961171 · Carl Zeiss, Inc. · Jun 1996
WELCH ALLYN VIDEO OPHTHALMOSCOPE
K951210 · Welch Allyn, Inc. · Jun 1995
WELCH ALLYN OPHTHALMOSCOPE
K950461 · Welch Allyn, Inc. · Apr 1995