Cleared Traditional

K992339 - COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS

K992339 is an FDA 510(k) clearance for COLORSOFT PROSTHETIC TINTED SOFT CONTAC..., manufactured by Colorsoft Laboratories Corp.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K992339 · Colorsoft Laboratories Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
34d
Days
Class 2
Risk

K992339 is an FDA 510(k) clearance for the COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Colorsoft Laboratories Corp. (Grand Junction, US). The FDA issued a Cleared decision on August 16, 1999 after a review of 34 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 Colorsoft Laboratories Corp. devices

FDA 510(k) Submission Details - K992339

510(k) Number K992339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1999
Decision Date August 16, 1999
Days to Decision 34 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
76d faster than avg
Panel avg: 110d · This submission: 34d
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 K992339.
OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR
K992466 · Ocu-Ease Optical Products, Inc. · Oct 1999
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY
K992589 · Opti-Centre Laboratories · Aug 1999
CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
K992500 · Cantor & Silver , Ltd. · Aug 1999
SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A)
K984090 · Specialty Ultravision, Inc. · Jul 1999
ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS
K992054 · Adventures IN Color Technology, Ltd. · Jul 1999
W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED)
K992010 · Westcon Contact Lens Co., Inc. · Jun 1999