Cleared Traditional

K021750 - LID CHAIN EYELID WEIGHTS (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K021750 · Jedmed Instrument Co. · Ophthalmic device
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Jan 2003
Decision
244d
Days
Class 2
Risk

K021750 is an FDA 510(k) clearance for the LID CHAIN EYELID WEIGHTS. Classified as Weights, Eyelid, External (product code MML), Class II - Special Controls.

Submitted by Jedmed Instrument Co. (Saint Louis, US). The FDA issued a Cleared decision on January 27, 2003 after a review of 244 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Jedmed Instrument Co. devices

Submission Details

510(k) Number K021750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2002
Decision Date January 27, 2003
Days to Decision 244 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 110d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.