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Altomed Malhotra Platinum Segments

by Altomed Limited

510(k) K170591

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170591 Date6 Jun 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MML
Device Class
Class II
Regulation
21 CFR Part 886.5700
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Malhotra Platinum Segments are eyelid weights designed to provide gravity-assisted treatment for lagophthalmos. These devices are sutured in a flexible chain format that molds to the contour of the patient's eye.

The Malhotra Platinum Segments are available in 0.2g and 0.4g sizes and should not be used on patients with known allergies to platinum, iridium or nickel. The device is FDA 510(k) cleared with product code MML and is classified as an ophthalmic device.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the Altomed Malhotra Platinum Segments used for?

    The Malhotra Platinum Segments are eyelid weights designed to provide gravity-assisted treatment for lagophthalmos. They are sutured in a flexible chain format that molds to the contour of the patient's eye.

  • What sizes are available for the Malhotra Platinum Segments?

    The Malhotra Platinum Segments are available in two sizes: 0.2g and 0.4g. These different weight options allow for customized treatment based on the patient's specific needs and the severity of their condition.

  • Are there any contraindications for using the Malhotra Platinum Segments?

    The device should not be used on patients with known allergies to platinum, iridium or nickel. These materials are part of the device composition, and allergic reactions could occur in sensitive individuals.

  • What is the regulatory status of the Malhotra Platinum Segments?

    The device is FDA 510(k) cleared with product code MML and is classified as an ophthalmic device. It received clearance through the traditional pathway with a decision code of SESE (Substantially Equivalent) on June 6, 2017.