Cleared Traditional

K052507 - TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR

K052507 is an FDA 510(k) clearance for TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE..., manufactured by The Lagado Corp.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K052507 · The Lagado Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
50d
Days
Class 2
Risk

K052507 is an FDA 510(k) clearance for the TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCA.... Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by The Lagado Corp. (Chicago, US). The FDA issued a Cleared decision on November 2, 2005 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - 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 The Lagado Corp. devices

FDA 510(k) Submission Details - K052507

510(k) Number K052507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2005
Decision Date November 02, 2005
Days to Decision 50 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 110d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQD Device Classification - Class 2, Special Controls

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
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 - HQD Lens, Contact (other Material) - Daily

All 45
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K052507.
OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
K070628 · Contamac, Ltd. · May 2007
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K062548 · Contamac, Ltd. · Nov 2006
BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
K053124 · Bausch & Lomb, Incorporated · Jan 2006
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K033594 · Contamac, Ltd. · Mar 2004
HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR
K021977 · Contamac, Ltd. · Sep 2002
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K022128 · Bausch & Lomb, Incorporated · Aug 2002