Cleared Traditional

K150986 - Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
(FDA 510(k) Clearance)

K150986 · Meddev Corporation · Ophthalmic

Aug 2015

Decision

125d

Days

Class 2

Risk

K150986 is an FDA 510(k) clearance for the Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants, a Weights, Eyelid, External (Class II — Special Controls, product code MML), submitted by Meddev Corporation (Sunnyvale, US). The FDA issued a Cleared decision on August 17, 2015, 125 days after receiving the submission on April 14, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5700.

Submission Details

510(k) Number	K150986 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2015
Decision Date	August 17, 2015
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

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)