Cleared Traditional

K063378 - CIRRUS HD-OCT, MODEL 4000

K063378 is an FDA 510(k) clearance for CIRRUS HD-OCT, manufactured by Carl Zeiss Meditec, Inc.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K063378 · Carl Zeiss Meditec, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
79d
Days
Class 2
Risk

K063378 is an FDA 510(k) clearance for the CIRRUS HD-OCT, MODEL 4000. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on January 26, 2007 after a review of 79 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 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 Carl Zeiss Meditec, Inc. devices

FDA 510(k) Submission Details - K063378

510(k) Number K063378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2006
Decision Date January 26, 2007
Days to Decision 79 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
31d faster than avg
Panel avg: 110d · This submission: 79d
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 Peers - HLI Ophthalmoscope, Ac-powered

All 70
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K063378.
AAIO-7, AAIO WIRLESS
K110205 · Appasamy Associates · Feb 2011
RTVUE MODEL RTVUE 100
K101505 · Optovue, Inc. · Sep 2010
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
K100861 · Optovue, Inc. · Jun 2010
VANTAGE INDIRECT OPHTHALMOSCOPE
K060822 · Keeler Instruments, Inc. · May 2006
VISANTE OCT
K051789 · Carl Zeiss Meditec, Inc. · Sep 2005
OCT-OPTHALMOSCOPE
K042885 · Ophthalmic Technologies, Inc. · Jan 2005