Cleared Traditional

K161622 - LensGiene Sterile Saline Solution

K161622 is the FDA 510(k) clearance for LensGiene Sterile Saline Solution by Optics Laboratory, Inc.. It is a Class 2 Ophthalmic device (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

Submission Details

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
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.

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 Peers - LPN Accessories, Soft Lens Products

All 52
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K161622.
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