Cleared Traditional

K974635 - PARAGON LENS CARE

K974635 is an FDA 510(k) clearance for PARAGON LENS CARE, manufactured by Paragon Vision Sciences. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K974635 · Paragon Vision Sciences · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
54d
Days
Class 2
Risk

K974635 is an FDA 510(k) clearance for the PARAGON LENS CARE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Paragon Vision Sciences (Mesa, US). The FDA issued a Cleared decision on February 4, 1998 after a review of 54 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.

FDA 510(k) Submission Details - K974635

510(k) Number K974635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1997
Decision Date February 04, 1998
Days to Decision 54 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
56d faster than avg
Panel avg: 110d · This submission: 54d
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 50
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K974635.
BONASSE CONTACT LENS CASE
K991206 · Bonasse Ent. Co., Ltd. · Jun 2000
PARAGON LENS CARRIER
K993486 · Paragon Vision Sciences · Dec 1999
PARAGON LENS VIAL
K993487 · Paragon Vision Sciences · Dec 1999
ALCON CONTACT LENS CASE
K974281 · Alcon Laboratories · Jan 1998
ALCON CONTACT LENS CASE
K971618 · Alcon Laboratories · Jul 1997
BOSTON CONTACT LENS CASE
K962512 · Polymer Technology Div. Wilmington Partners, L.P. · Jul 1996