Cleared Traditional

K053044 - OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5

K053044 is an FDA 510(k) clearance for OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTE..., manufactured by Opto Global, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K053044 · Opto Global, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
88d
Days
Class 2
Risk

K053044 is an FDA 510(k) clearance for the OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Opto Global, Inc. (Granite Bay, US). The FDA issued a Cleared decision on January 24, 2006 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Opto Global, Inc. devices

FDA 510(k) Submission Details - K053044

510(k) Number K053044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2005
Decision Date January 24, 2006
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 110d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 - HKI Camera, Ophthalmic, Ac-powered

All 88
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K053044.
CF-1
K063717 · Canon, Inc. · Jan 2007
KOWA VX-10I
K062021 · Kowa Co. , Ltd. · Nov 2006
KOWA NONMYD ALPHA-D
K062356 · Kowa Co. , Ltd. · Sep 2006
KOWA NONMYD 7, KOWA NONMYD A-D
K053026 · Kowa Co. , Ltd. · Nov 2005
KOWA GENESIS-D HAND-HELD RETINAL CAMERA
K050271 · Kowa Co. , Ltd. · Nov 2005
VISUCAM PRO NM
K052268 · Carl Zeiss Meditec, AG · Nov 2005