Cleared Special

K192129 - ClearColor 1-day (hioxifilcon A) Daily ...

K192129 is the FDA 510(k) clearance for ClearColor 1-day (hioxifilcon A) Daily ... by Clearlab SG Pte, Ltd.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Special 510(k) pathway after a 51-day FDA review.

K192129 · Clearlab SG Pte, Ltd. · Ophthalmic device
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Sep 2019
Decision
51d
Days
Class 2
Risk

K192129 is an FDA 510(k) clearance for the ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact .... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Clearlab SG Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on September 27, 2019 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. 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.

View all Clearlab SG Pte, Ltd. devices

Submission Details

510(k) Number K192129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2019
Decision Date September 27, 2019
Days to Decision 51 days
Submission Type Special
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
Modification to existing cleared device.

Device Classification

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 Consultant

Clearlab Us, Inc.
John Christopher Phelan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 160
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K192129.
ACUVUE (senofilcon A) Soft Contact Lens Multifocal
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K183670 · Visco Vision, Inc. · Sep 2019
Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens
K191121 · Lentechs, LLC · Sep 2019