Cleared Abbreviated

K061278 - OPTYSE OPHTHALMOSCOPE

K061278 is an FDA 510(k) clearance for OPTYSE OPHTHALMOSCOPE, manufactured by Ophthalmos , Ltd.. The device is a Class 2 Ophthalmic device with product code HLJ cleared through the Abbreviated 510(k) pathway after a 8-day FDA review.

K061278 · Ophthalmos , Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
8d
Days
Class 2
Risk

K061278 is an FDA 510(k) clearance for the OPTYSE OPHTHALMOSCOPE. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Ophthalmos , Ltd. (Ickleton, Cambridge, GB). The FDA issued a Cleared decision on May 16, 2006 after a review of 8 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K061278

510(k) Number K061278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2006
Decision Date May 16, 2006
Days to Decision 8 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 110d · This submission: 8d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

HLJ Device Classification - Class 2, Special Controls

Product Code HLJ Ophthalmoscope, Battery-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

Intertek Testing Services
NEIL E DEVINE

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 - HLJ Ophthalmoscope, Battery-powered

All 40
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K061278.
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
K093495 · American Diagnostic Corp. · Nov 2010
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
K070270 · Kirchner & Wilhelm GmbH + Co.Kg · Nov 2007
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
K052599 · Suzhou 66 Vision-Tech Co., Ltd. · Nov 2006
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
K053425 · Precision Optics Corp. · Jan 2006
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
K032087 · Keeler Instruments, Inc. · Nov 2003
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
K002044 · Magna Fortis Corporation · Sep 2000
K061278 · OPTYSE OPHTHALMOSCOPE
Download PDF FDA Summary Ophthalmos , Ltd.