Cleared Traditional

K990224 - LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET

K990224 is an FDA 510(k) clearance for LABTICIAN LID LOAD EXTERNAL EYELID SIZI..., manufactured by Labtician Ophthalmics, Inc.. The device is a Class 2 Ophthalmic device with product code MML cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K990224 · Labtician Ophthalmics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
77d
Days
Class 2
Risk

K990224 is an FDA 510(k) clearance for the LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET. Classified as Weights, Eyelid, External (product code MML), Class II - Special Controls.

Submitted by Labtician Ophthalmics, Inc. (Oakville, Ontario, CA). The FDA issued a Cleared decision on April 12, 1999 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5700 - 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 Labtician Ophthalmics, Inc. devices

FDA 510(k) Submission Details - K990224

510(k) Number K990224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1999
Decision Date April 12, 1999
Days to Decision 77 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
33d faster than avg
Panel avg: 110d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MML Device Classification - Class 2, Special Controls

Product Code MML Weights, Eyelid, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5700
Definition Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure)
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 - MML Weights, Eyelid, External

All 7
Devices cleared under the same product code (MML) and FDA review panel - the closest regulatory comparables to K990224.
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
K150986 · Meddev Corporation · Aug 2015
LID CHAIN EYELID WEIGHTS
K021750 · Jedmed Instrument Co. · Jan 2003
SUTUREGROOVE
K994289 · Iop, Inc. · Apr 2000
LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS
K983607 · Labtician Ophthalmics, Inc. · Jan 1999
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
K971242 · Ipax, Inc. · Dec 1997
BLINK EXTERNAL EYELID WEIGHT
K971245 · Ipax, Inc. · Jun 1997