Cleared Traditional

K950530 - PRO-TEC-CASE

K950530 is an FDA 510(k) clearance for PRO-TEC-CASE, manufactured by Hyman, Phelps & McNamara, P.C.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K950530 · Hyman, Phelps & McNamara, P.C. · Ophthalmic device
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Apr 1995
Decision
59d
Days
Class 2
Risk

K950530 is an FDA 510(k) clearance for the PRO-TEC-CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Hyman, Phelps & McNamara, P.C. (Washington Dc, US). The FDA issued a Cleared decision on April 7, 1995 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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 Hyman, Phelps & McNamara, P.C. devices

FDA 510(k) Submission Details - K950530

510(k) Number K950530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1995
Decision Date April 07, 1995
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 110d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRX Device Classification - Class 2, Special Controls

Product Code LRX Case, Contact Lens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LRX Case, Contact Lens

All 41
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K950530.
ALCON CONTACT LENS CASE
K971618 · Alcon Laboratories · Jul 1997
BOSTON CONTACT LENS CASE
K962512 · Polymer Technology Div. Wilmington Partners, L.P. · Jul 1996
BOSTON CONTACT LENS CASE
K951552 · Polymer Technology Corp. · Jun 1995
CIBA VISION(R) CONTACT LENS CASE
K943183 · Ciba Vision Corporation · Aug 1994
OPTI-FREE CONTACT LENS CASE
K931620 · Alcon Laboratories · Jun 1993
BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM
K896685 · Bausch & Lomb, Inc. · Dec 1989