Cleared Traditional

K013232 - CYBERCASES BY BAUSCH & LOMB

K013232 is an FDA 510(k) clearance for CYBERCASES BY BAUSCH & LOMB, manufactured by Bausch & Lomb, Inc.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K013232 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Nov 2001
Decision
54d
Days
Class 2
Risk

K013232 is an FDA 510(k) clearance for the CYBERCASES BY BAUSCH & LOMB. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on November 20, 2001 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bausch & Lomb, Inc. devices

FDA 510(k) Submission Details - K013232

510(k) Number K013232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2001
Decision Date November 20, 2001
Days to Decision 54 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
56d faster than avg
Panel avg: 110d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRX Device Classification - Class 2, Special Controls

Product Code LRX Case, Contact Lens
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 - LRX Case, Contact Lens

All 27
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K013232.
EYE CARE CURE CONTACT LENS CASE
K112832 · Eye Care and Cure · Dec 2011
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
K111856 · Apothecary Products, Inc. · Jul 2011
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · Ciba Vision Corporation · Sep 2005
BONASSE CONTACT LENS CASE
K991206 · Bonasse Ent. Co., Ltd. · Jun 2000
PARAGON LENS CARRIER
K993486 · Paragon Vision Sciences · Dec 1999
PARAGON LENS VIAL
K993487 · Paragon Vision Sciences · Dec 1999