Cleared Traditional

CILCO ANTERIOR CHAMBER LENS (K771933) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K771933 · California Intraocular Lens · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1978
Decision
104d
Days
Class 3
Risk

K771933 is an FDA 510(k) clearance for the CILCO ANTERIOR CHAMBER LENS. Classified as Intraocular Lens (product code HQL), Class III - Premarket Approval.

Submitted by California Intraocular Lens (Mchenry, US). The FDA issued a Cleared decision on January 26, 1978 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3600 - 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all California Intraocular Lens devices

Submission Details

510(k) Number K771933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1977
Decision Date January 26, 1978
Days to Decision 104 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 110d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQL Intraocular Lens
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 886.3600
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.