Cleared Traditional

Altomed Malhotra Platinum Segments

K170591 · Altomed Limited · Ophthalmic

Jun 2017

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K170591 is an FDA 510(k) clearance for the Altomed Malhotra Platinum Segments, a Weights, Eyelid, External (Class II — Special Controls, product code MML), submitted by Altomed Limited (Bolden, Tyne And Wear, GB). The FDA issued a Cleared decision on June 6, 2017, 98 days after receiving the submission on February 28, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5700.

Submission Details

510(k) Number	K170591 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2017
Decision Date	June 06, 2017
Days to Decision	98 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)