Cleared Traditional

K944895 - BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS

K944895 is an FDA 510(k) clearance for BAUSCH & LOMB PREMIER 90 (BALAFILCON A)..., manufactured by Bausch & Lomb, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K944895 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
76d
Days
Class 2
Risk

K944895 is an FDA 510(k) clearance for the BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS. 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 19, 1994 after a review of 76 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K944895

510(k) Number K944895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1994
Decision Date December 19, 1994
Days to Decision 76 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
34d faster than avg
Panel avg: 110d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K944895.
LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENS
K950283 · Permeable Technologies, Inc. · Feb 1995
PRECISION UV(TM) (VASURFICON A)
K946012 · Pilkington Barnes-Hind, Ltd. · Jan 1995
HORIZON 55 BI-CON
K945365 · Westcon Contact Lens Co., Inc. · Dec 1994
OCU-FLEX-38 (POLYMACON)
K941998 · Ocu-Ease Optical Products, Inc. · Oct 1994
PRECISION UV(TM) (VASURFILCON A)
K944722 · Pilkington Barnes-Hind, Ltd. · Oct 1994
LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS
K942494 · Permeable Technologies, Inc. · Sep 1994
K944895 · BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
Download PDF FDA Summary Bausch & Lomb, Inc.