Cleared Traditional

K161622 - LensGiene Sterile Saline Solution

K161622 is an FDA 510(k) clearance for LensGiene Sterile Saline Solution, manufactured by Optics Laboratory, Inc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K161622 · Optics Laboratory, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Aug 2016
Decision
59d
Days
Class 2
Risk

K161622 is an FDA 510(k) clearance for the LensGiene Sterile Saline Solution. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Optics Laboratory, Inc. (El Monte, US). The FDA issued a Cleared decision on August 11, 2016 after a review of 59 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. 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 Optics Laboratory, Inc. devices

FDA 510(k) Submission Details - K161622

510(k) Number K161622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2016
Decision Date August 11, 2016
Days to Decision 59 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
51d faster than avg
Panel avg: 110d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPN Device Classification - Class 2, Special Controls

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

Rockin' Regulatory, Inc.
Paul Kramsky

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

All 85
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K161622.
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BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
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