Cleared Traditional

K082944 - CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

K082944 is the FDA 510(k) clearance for CRYSTALSERT CRYSTALENS DELIVERY SYSTEM by Bausch & Lomb, Inc.. It is a Class 1 Ophthalmic device (product code MSS) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

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
Combination Product No
PCCP Authorized No
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 Consultant

Intertek Testing Services
JAY Y KOGOMA

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.