Cleared Traditional

PuriLens Plus Preservative Free Saline (K200747) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200747 · The Lifestyle Company, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
May 2020
Decision
53d
Days
Class 2
Risk

K200747 is an FDA 510(k) clearance for the PuriLens Plus Preservative Free Saline. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by The Lifestyle Company, Inc. (Freehold, US). The FDA issued a Cleared decision on May 15, 2020 after a review of 53 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 The Lifestyle Company, Inc. devices

Submission Details

510(k) Number K200747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2020
Decision Date May 15, 2020
Days to Decision 53 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
57d faster than avg
Panel avg: 110d · This submission: 53d
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 Consultant

Emergo Global Consulting, LLC
Michael A. Siano

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 119
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K200747.
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