Cleared Traditional

K200057 - bioli lOL Delivery System

K200057 is an FDA 510(k) clearance for bioli lOL Delivery System, manufactured by Ast Products, Inc.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K200057 · Ast Products, Inc. · Ophthalmic device
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Jun 2020
Decision
143d
Days
Class 1
Risk

K200057 is an FDA 510(k) clearance for the bioli lOL Delivery System. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Ast Products, Inc. (Billerica, US). The FDA issued a Cleared decision on June 4, 2020 after a review of 143 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 Ast Products, Inc. devices

FDA 510(k) Submission Details - K200057

510(k) Number K200057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2020
Decision Date June 04, 2020
Days to Decision 143 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
33d slower than avg
Panel avg: 110d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

MSS Device Classification - Class 1, General Controls

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 42
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