Cleared Traditional

K970312 - CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)

K970312 is an FDA 510(k) clearance for CONTROLLED PROCESS RELEASE OF FLEXLENS ..., manufactured by Flexlens, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K970312 · Flexlens, Inc. · Ophthalmic device
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Apr 1997
Decision
65d
Days
Class 2
Risk

K970312 is an FDA 510(k) clearance for the CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A). Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Flexlens, Inc. (Englewood, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 65 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.

View all Flexlens, Inc. devices

FDA 510(k) Submission Details - K970312

510(k) Number K970312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1997
Decision Date April 02, 1997
Days to Decision 65 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
45d faster than avg
Panel avg: 110d · This submission: 65d
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 191
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K970312.
D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES
K965052 · Wesley Jessen Corp. · May 1997
SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
K970746 · Ciba Vision Corporation · May 1997
PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS
K970095 · Biocompatibles Eyewear, Inc. · Apr 1997
MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
K970019 · Menicon U.S.A., Inc. · Mar 1997
PROMED 55-G SOFT DAILY WEAR CONTACT LENS
K970615 · Biomed Devices Corp. · Mar 1997
CONTACT LENSES METRO-G 3X (HIOXIFILCON B)
K964902 · Metro Optics of Austin, Inc. · Mar 1997