Cleared Traditional

K003646 - SUTUREGROOVE WEIGHT SIZING SET

K003646 is an FDA 510(k) clearance for SUTUREGROOVE WEIGHT SIZING SET, manufactured by Iop, Inc.. The device is a Class 2 Ophthalmic device with product code MML cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K003646 · Iop, Inc. · Ophthalmic device
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Feb 2001
Decision
87d
Days
Class 2
Risk

K003646 is an FDA 510(k) clearance for the SUTUREGROOVE WEIGHT SIZING SET. Classified as Weights, Eyelid, External (product code MML), Class II - Special Controls.

Submitted by Iop, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on February 22, 2001 after a review of 87 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.

FDA 510(k) Submission Details - K003646

510(k) Number K003646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 27, 2000
Decision Date February 22, 2001
Days to Decision 87 days
Submission Type Traditional
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
23d faster than avg
Panel avg: 110d · This submission: 87d
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 13
Devices cleared under the same product code (MML) and FDA review panel - the closest regulatory comparables to K003646.
LID CHAIN EYELID WEIGHTS
K021750 · Jedmed Instrument Co. · Jan 2003
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
K011740 · Meddev Corp. · Jul 2001
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
K011115 · Heinz Kurz GmbH Medizintechnik · May 2001
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
K001123 · Heinz Kurz GmbH Medizintechnik · Apr 2000
SUTUREGROOVE
K994289 · Iop, Inc. · Apr 2000
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
K000127 · Heinz Kurz GmbH Medizintechnik · Apr 2000
K003646 · SUTUREGROOVE WEIGHT SIZING SET
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