Cleared Traditional

K011234 - BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L

K011234 is an FDA 510(k) clearance for BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL..., manufactured by American Biocurve, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K011234 · American Biocurve, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
51d
Days
Class 2
Risk

K011234 is an FDA 510(k) clearance for the BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by American Biocurve, Inc. (Grand Junction, US). The FDA issued a Cleared decision on June 13, 2001 after a review of 51 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.

FDA 510(k) Submission Details - K011234

510(k) Number K011234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2001
Decision Date June 13, 2001
Days to Decision 51 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
59d faster than avg
Panel avg: 110d · This submission: 51d
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 489
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K011234.
S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY-
K002099 · Bescon Co., Ltd. · Jul 2001
SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D)
K011542 · Specialty Ultravision, Inc. · Jun 2001
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S
K011577 · Ocu-Ease Optical Products, Inc. · Jun 2001
BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T
K011316 · American Contact Lens, Inc. · Jun 2001
POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS)
K004049 · Optech, Inc. · May 2001
SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C
K011089 · Specialty Ultravision, Inc. · May 2001
K011234 · BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L
Download PDF FDA Summary American Biocurve, In…