Cleared Traditional

K983607 - LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS

K983607 is an FDA 510(k) clearance for LABTICIAN LID LOAD GOLD EYELID WEIGHT I..., 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 86-day FDA review.

K983607 · Labtician Ophthalmics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Jan 1999
Decision
86d
Days
Class 2
Risk

K983607 is an FDA 510(k) clearance for the LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS. 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 January 8, 1999 after a review of 86 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 - K983607

510(k) Number K983607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1998
Decision Date January 08, 1999
Days to Decision 86 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
24d faster than avg
Panel avg: 110d · This submission: 86d
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 K983607.
LID CHAIN EYELID WEIGHTS
K021750 · Jedmed Instrument Co. · Jan 2003
SUTUREGROOVE
K994289 · Iop, Inc. · Apr 2000
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
K990224 · Labtician Ophthalmics, Inc. · Apr 1999
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
K971242 · Ipax, Inc. · Dec 1997
BLINK EXTERNAL EYELID WEIGHT
K971245 · Ipax, Inc. · Jun 1997