Cleared Traditional

LID CHAIN EYELID WEIGHTS

K021750 · Jedmed Instrument Co. · Ophthalmic

Jan 2003

Decision

244d

Days

Class 2

Risk

About This 510(k) Submission

K021750 is an FDA 510(k) clearance for the LID CHAIN EYELID WEIGHTS, a Weights, Eyelid, External (Class II — Special Controls, product code MML), submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on January 27, 2003, 244 days after receiving the submission on May 28, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5700.

Submission Details

510(k) Number	K021750 FDA.gov
FDA Decision	Cleared 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

Device Classification

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