Cleared Traditional

K142953 - OCT-Camera

K142953 is an FDA 510(k) clearance for OCT-Camera, manufactured by Optomedical Technologies GmbH. The device is a Class 2 Ophthalmic device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K142953

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Emergo Group
Dirk Meier

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HLI Ophthalmoscope, Ac-powered

All 70
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