Cleared Special

K042242 - ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES

K042242 is an FDA 510(k) clearance for ALDEN HP (HIOXIFILCON B) SPHERE & TORIC..., manufactured by Alden Optical Labs., Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Special 510(k) pathway after a 27-day FDA review.

K042242 · Alden Optical Labs., Inc. · Ophthalmic device
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Sep 2004
Decision
27d
Days
Class 2
Risk

K042242 is an FDA 510(k) clearance for the ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Alden Optical Labs., Inc. (Alden, US). The FDA issued a Cleared decision on September 15, 2004 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K042242

510(k) Number K042242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2004
Decision Date September 15, 2004
Days to Decision 27 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 110d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K042242.
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K042824 · CooperVision, Inc. · Nov 2004
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K042275 · Vistakon · Oct 2004
COOPER PROSTHETIC
K042435 · CooperVision, Inc. · Oct 2004
SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
K033655 · Soflex Contact Lens Industries , Ltd. · Jul 2004
CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR
K041700 · Cantor & Nissel , Ltd. · Jul 2004
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
K041138 · CooperVision, Inc. · Jul 2004
K042242 · ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES
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