Cleared Traditional

K063717 - CF-1

K063717 is an FDA 510(k) clearance for CF-1, manufactured by Canon, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K063717 · Canon, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
40d
Days
Class 2
Risk

K063717 is an FDA 510(k) clearance for the CF-1. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Canon, Inc. (Lake Success, US). The FDA issued a Cleared decision on January 23, 2007 after a review of 40 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 Canon, Inc. devices

FDA 510(k) Submission Details - K063717

510(k) Number K063717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2006
Decision Date January 23, 2007
Days to Decision 40 days
Submission Type Traditional
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
70d faster than avg
Panel avg: 110d · This submission: 40d
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 Consultant

Underwriters Laboratories, Inc.
JEFFREY D RONGERO

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 - HKI Camera, Ophthalmic, Ac-powered

All 104
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K063717.
KOWA NONMYD ALPHA-DIII
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CR-1
K080883 · Canon, Inc. · Apr 2008
KOWA GENESIS-D
K080681 · Kowa Co. , Ltd. · Apr 2008
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