Cleared Traditional

K991995 - SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS

K991995 is an FDA 510(k) clearance for SOFTCHROME TINTS, manufactured by Softchrome, Inc.. The device is a Class 2 Ophthalmic device with product code MZD cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K991995 · Softchrome, Inc. · Ophthalmic device
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Aug 1999
Decision
74d
Days
Class 2
Risk

K991995 is an FDA 510(k) clearance for the SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS. Classified as System, In-office Tinting, Contact Lenses (product code MZD), Class II - Special Controls.

Submitted by Softchrome, Inc. (Grand Junction, US). The FDA issued a Cleared decision on August 27, 1999 after a review of 74 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 Softchrome, Inc. devices

FDA 510(k) Submission Details - K991995

510(k) Number K991995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1999
Decision Date August 27, 1999
Days to Decision 74 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
36d faster than avg
Panel avg: 110d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MZD Device Classification - Class 2, Special Controls

Product Code MZD System, In-office Tinting, Contact Lenses
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.