Cleared Traditional

K122575 - BAUSCH & LOMB PUREVISION (BALAFILCON A)...

K122575 is the FDA 510(k) clearance for BAUSCH & LOMB PUREVISION (BALAFILCON A)... by Bausch & Lomb, Inc.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K122575 · Bausch & Lomb, Inc. · Ophthalmic device
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Dec 2012
Decision
119d
Days
Class 2
Risk

K122575 is an FDA 510(k) clearance for the BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSC.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on December 20, 2012 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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 Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K122575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2012
Decision Date December 20, 2012
Days to Decision 119 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
9d slower than avg
Panel avg: 110d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
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 - LPL Lenses, Soft Contact, Daily Wear

All 139
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K122575.
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
K131208 · Bausch & Lomb, Inc. · Sep 2013
SUS (STENFILCON A) CONTACT LENS
K131378 · CooperVision, Inc. · Aug 2013
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
K123202 · CooperVision, Inc. · May 2013
AVAIRA (ENFILCON A) CONTACT LENS
K113759 · CooperVision, Inc. · Apr 2012
PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES
K112302 · CooperVision, Inc. · Dec 2011
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
K113245 · CooperVision, Inc. · Dec 2011