Cleared Traditional

K110221 - EYE-CEPT STERILE SALINE SOLUTION

K110221 is an FDA 510(k) clearance for EYE-CEPT STERILE SALINE SOLUTION, manufactured by Optics Laboratory, Inc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K110221 · Optics Laboratory, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
280d
Days
Class 2
Risk

K110221 is an FDA 510(k) clearance for the EYE-CEPT STERILE SALINE SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Optics Laboratory, Inc. (El Monte, US). The FDA issued a Cleared decision on November 1, 2011 after a review of 280 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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 Optics Laboratory, Inc. devices

FDA 510(k) Submission Details - K110221

510(k) Number K110221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2011
Decision Date November 01, 2011
Days to Decision 280 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
170d slower than avg
Panel avg: 110d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPN Device Classification - Class 2, Special Controls

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LPN Accessories, Soft Lens Products

All 85
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