Cleared Traditional

K952152 - PROCLEAR DAILY WEAR CONTACT LENS

K952152 is an FDA 510(k) clearance for PROCLEAR DAILY WEAR CONTACT LENS, manufactured by Biocompatibles , Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K952152 · Biocompatibles , Ltd. · Ophthalmic device
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Jul 1995
Decision
80d
Days
Class 2
Risk

K952152 is an FDA 510(k) clearance for the PROCLEAR DAILY WEAR CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Biocompatibles , Ltd. (Middlesex, England, GB). The FDA issued a Cleared decision on July 27, 1995 after a review of 80 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 - K952152

510(k) Number K952152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date July 27, 1995
Days to Decision 80 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 110d · This submission: 80d
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 K952152.
AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K954139 · CooperVision, Inc. · Nov 1995
LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55 (OCUFILCON D) GHYDROPHILIC CONTACT LENS
K951893 · Permeable Technologies, Inc. · Nov 1995
VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS
K953804 · Vistakon, Johnson & Johnson Vision Products, Inc. · Sep 1995
TETRAFILCON A HYDROPHILIC CONTACT LENSES
K950968 · CooperVision, Inc. · Jul 1995
HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55%
K952261 · Pilkington Barnes-Hind, Ltd. · Jul 1995
ALLURE (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
K942374 · Sunsoft Corp. · Apr 1995
K952152 · PROCLEAR DAILY WEAR CONTACT LENS
Download PDF Biocompatibles , Ltd.