510(k) Report

510(k) · Cleared

Cleared

Altomed Malhotra Platinum Segments

K170591510(k) TraditionalCleared Jun 6, 201798-day reviewClass II21 CFR 886.5700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Altomed Limited · MML Weights, Eyelid, External

Cleared on Jun 6, 2017 as substantially equivalent to K011115 (Heinz Kurz GmbH Medizintechnik, 2001) after a 98-day review. Its family tree reaches back 1 generation to 2001.

Decided
Jun 6, 2017
Review
98 days
Class
Class II
Product code
MML
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011115 (2001). No later device cites it as a predicate yet.

K011115 · Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010 · Heinz Kurz GmbH Medizintechnik · 20012000200520102015
K011115 · Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010 · Heinz Kurz GmbH Medizintechnik · 20010
  1. Root · 1 generation backK011115 Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007…Heinz Kurz GmbH Medizintechnik · 2001
  2. This deviceK170591 Altomed Malhotra Platinum SegmentsAltomed Limited · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011115Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007…Heinz Kurz GmbH Medizintechnik2001—
0 (this device)K170591Altomed Malhotra Platinum SegmentsAltomed Limited2017—
FIG. 1 — Lineage of K170591, 2001–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MML? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K011115Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007…
Summary page 4
…Segments Device Common Name: Implantable Eyelid Weight Classification: Class II Classification Name: Implantable Eyelid Weight Product Code: MML 3. Predicate Device: K011115, Heinz Kurz Platinum Implants 4. Device Description: Sterile, single use, eyelid weight implant segments, used to treat Lagopht…
Heinz Kurz GmbH Medizintechnik2001—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All MML devices

MML Weights, Eyelid, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · MML

1in 2017

2015: 12017: 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MML

Too few MML 510(k)s in any year since 2007 to give a median.

Recalls per year · MML

No recall names MML since 2007.

Adverse event reports per year · MML

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2025

MAUDE reports naming product code MML, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

Malhotra Platinum Segments are eyelid implants designed for the gravity-assisted treatment of lagophthalmos.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in MML

The MML category page

  • K150986Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMeddev Corporation · 20152 recalls
  • K021750Lid Chain Eyelid WeightsJedmed Instrument Co. · 2003
  • K011740Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000)Meddev Corp. · 2001
  • K011115Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010Heinz Kurz GmbH Medizintechnik · 2001
  • K003646Suturegroove Weight Sizing SetIop, Inc. · 2001

https://510kreport.com/device/K170591 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170591: Altomed Malhotra Platinum Segments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170591

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026