Cleared Traditional

K993489 - CRYSTAL CUSTOM TINTED SOFT CONTACT LENS

K993489 is an FDA 510(k) clearance for CRYSTAL CUSTOM TINTED SOFT CONTACT LENS, manufactured by Crystal Reflections, Int., Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K993489 · Crystal Reflections, Int., Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
182d
Days
Class 2
Risk

K993489 is an FDA 510(k) clearance for the CRYSTAL CUSTOM TINTED SOFT CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Crystal Reflections, Int., Inc. (Front Royal, US). The FDA issued a Cleared decision on April 14, 2000 after a review of 182 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Crystal Reflections, Int., Inc. devices

FDA 510(k) Submission Details - K993489

510(k) Number K993489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1999
Decision Date April 14, 2000
Days to Decision 182 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
72d slower than avg
Panel avg: 110d · This submission: 182d
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 K993489.
METHAFILCON A
K002625 · CooperVision, Inc. · Sep 2000
POLYMACON
K001089 · CooperVision, Inc. · May 2000
METHAFILCON A
K001090 · CooperVision, Inc. · May 2000
PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS
K994335 · Wesley Jessen Corp. · Mar 2000
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
K000384 · CooperVision, Inc. · Mar 2000
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES
K994125 · Bausch & Lomb, Inc. · Mar 2000