Cleared Special

AOCup Lens Case with AODisc (K191795) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191795 · Alcon Laboratories, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
28d
Days
Class 2
Risk

K191795 is an FDA 510(k) clearance for the AOCup Lens Case with AODisc. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on July 31, 2019 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alcon Laboratories, Inc. devices

Submission Details

510(k) Number K191795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2019
Decision Date July 31, 2019
Days to Decision 28 days
Submission Type Special
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
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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

Ciba Vision GmbH
Ralf Finke

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 - LPN Accessories, Soft Lens Products

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