510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170591Substantially Equivalent

Altomed Malhotra Platinum Segments

Altomed Ltd., Bolden, Tyne And Wear, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170591 is the FDA 510(k) clearance record for Altomed Malhotra Platinum Segments, a class II device, cleared for Altomed Limited on under FDA product code MML (Weights, Eyelid, External). FDA's definition for product code MML reads: "Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)". FDA records list one 510(k) clearance for Altomed Limited. As of , FDA records show no recalls naming K170591.

Clearance record

Decision date
Received
(98 days to decision)
Product code
MML Weights, Eyelid, External
Regulation
21 CFR 886.5700
Device class
Class II
Review panel
Ophthalmic
Applicant
Altomed Limited 2 Whitney Way, Bolden, Tyne And Wear, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MML

Trailing 12 months

FDA records hold no clearances under product code MML in the trailing twelve months.

FDA records show no clearances under product code MML in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MML, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260