Cleared Traditional

MASTEL 1 FOLDER IMPLANTATION SYSTEM (K022723) - FDA 510(k) Clearance

Class I Ophthalmic device.

K022723 · Mastel Precision, Inc. · Ophthalmic device
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Dec 2002
Decision
132d
Days
Class 1
Risk

K022723 is an FDA 510(k) clearance for the MASTEL 1 FOLDER IMPLANTATION SYSTEM. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Mastel Precision, Inc. (Irvine, US). The FDA issued a Cleared decision on December 26, 2002 after a review of 132 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Mastel Precision, Inc. devices

Submission Details

510(k) Number K022723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2002
Decision Date December 26, 2002
Days to Decision 132 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
22d slower than avg
Panel avg: 110d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYB Lens, Guide, Intraocular
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.