Cleared Traditional

K161776 - Lenstec LC Injection system

K161776 is an FDA 510(k) clearance for Lenstec LC Injection system, manufactured by Lenstec, Inc.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K161776 · Lenstec, Inc. · Ophthalmic device
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Nov 2016
Decision
153d
Days
Class 1
Risk

K161776 is an FDA 510(k) clearance for the Lenstec LC Injection system. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Lenstec, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on November 29, 2016 after a review of 153 days - an extended review 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: 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 Lenstec, Inc. devices

FDA 510(k) Submission Details - K161776

510(k) Number K161776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2016
Decision Date November 29, 2016
Days to Decision 153 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
43d slower than avg
Panel avg: 110d · This submission: 153d
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
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K161776.
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One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
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