Cleared Traditional

K983637 - ACTIFRESH 400 LENS

K983637 is an FDA 510(k) clearance for ACTIFRESH 400 LENS, manufactured by Hydron , Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 420-day FDA review.

K983637 · Hydron , Ltd. · Ophthalmic device
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Dec 1999
Decision
420d
Days
Class 2
Risk

K983637 is an FDA 510(k) clearance for the ACTIFRESH 400 LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Hydron , Ltd. (Farnborough, Hants, GB). The FDA issued a Cleared decision on December 10, 1999 after a review of 420 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Hydron , Ltd. devices

FDA 510(k) Submission Details - K983637

510(k) Number K983637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1998
Decision Date December 10, 1999
Days to Decision 420 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
310d slower than avg
Panel avg: 110d · This submission: 420d
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 279
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K983637.
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
K994324 · Vistakon, Johnson & Johnson Vision Products, Inc. · Feb 2000
SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K993580 · Specialty Ultravision, Inc. · Feb 2000
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI
K993935 · Wesley Jessen Corp. · Dec 1999
OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
K992264 · Ocular Sciences Puerto Rico, Inc. · Nov 1999
CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS
K992950 · Prosthetic Soft Lens Corp. · Nov 1999
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
K991015 · Lamda Polytech , Ltd. · Nov 1999