Cleared Traditional

CRYSTALSERT CRYSTALENS DELIVERY SYSTEM (K082944) - FDA 510(k) Clearance

Class I Ophthalmic device.

K082944 · Bausch & Lomb, Inc. · Ophthalmic device
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Oct 2008
Decision
14d
Days
Class 1
Risk

K082944 is an FDA 510(k) clearance for the CRYSTALSERT CRYSTALENS DELIVERY SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on October 16, 2008 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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 Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K082944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2008
Decision Date October 16, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 110d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code MSS Folders And Injectors, Intraocular Lens (iol)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSS Folders And Injectors, Intraocular Lens (iol)

All 61
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