Cleared Traditional

K945110 - KOLBERG OPHTHALMIC CONFORMER

K945110 is an FDA 510(k) clearance for KOLBERG OPHTHALMIC CONFORMER, manufactured by Kolberg Ocular Products, Inc.. The device is a Class 2 Ophthalmic device with product code HQN cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K945110 · Kolberg Ocular Products, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Jan 1995
Decision
87d
Days
Class 2
Risk

K945110 is an FDA 510(k) clearance for the KOLBERG OPHTHALMIC CONFORMER. Classified as Conformer, Ophthalmic (product code HQN), Class II - Special Controls.

Submitted by Kolberg Ocular Products, Inc. (San Diego, US). The FDA issued a Cleared decision on January 13, 1995 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3130 - 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 Kolberg Ocular Products, Inc. devices

FDA 510(k) Submission Details - K945110

510(k) Number K945110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1994
Decision Date January 13, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQN Device Classification - Class 2, Special Controls

Product Code HQN Conformer, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3130
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 - HQN Conformer, Ophthalmic

Devices cleared under the same product code (HQN) and FDA review panel - the closest regulatory comparables to K945110.
MEDPOR OCULAR CONFORMER
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K921221 · Storz Instrument Co. · Jul 1992
STERILE/SINGLE USE OPHTHALMIC CONFORMERS
K921229 · Storz Instrument Co. · Jun 1992