Cleared Traditional

K992950 - CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS

K992950 is an FDA 510(k) clearance for CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS, manufactured by Prosthetic Soft Lens Corp.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K992950 · Prosthetic Soft Lens Corp. · Ophthalmic device
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Nov 1999
Decision
78d
Days
Class 2
Risk

K992950 is an FDA 510(k) clearance for the CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Prosthetic Soft Lens Corp. (Englewood, US). The FDA issued a Cleared decision on November 18, 1999 after a review of 78 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 Prosthetic Soft Lens Corp. devices

FDA 510(k) Submission Details - K992950

510(k) Number K992950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1999
Decision Date November 18, 1999
Days to Decision 78 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
32d faster than avg
Panel avg: 110d · This submission: 78d
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 K992950.
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI
K993935 · Wesley Jessen Corp. · Dec 1999
ACTIFRESH 400 LENS
K983637 · Hydron , Ltd. · Dec 1999
OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
K992264 · Ocular Sciences Puerto Rico, Inc. · Nov 1999
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
K991015 · Lamda Polytech , Ltd. · Nov 1999
EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS
K992692 · Benz Research and Development Corp. · Oct 1999
OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR
K992466 · Ocu-Ease Optical Products, Inc. · Oct 1999