Cleared Traditional

K170591 - Altomed Malhotra Platinum Segments

K170591 is an FDA 510(k) clearance for Altomed Malhotra Platinum Segments, manufactured by Altomed Limited. The device is a Class 2 Ophthalmic device with product code MML cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K170591 · Altomed Limited · Ophthalmic device
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Jun 2017
Decision
98d
Days
Class 2
Risk

K170591 is an FDA 510(k) clearance for the Altomed Malhotra Platinum Segments. Classified as Weights, Eyelid, External (product code MML), Class II - Special Controls.

Submitted by Altomed Limited (Bolden, Tyne And Wear, GB). The FDA issued a Cleared decision on June 6, 2017 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5700 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Altomed Limited devices

FDA 510(k) Submission Details - K170591

510(k) Number K170591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 110d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MML Device Classification - Class 2, Special Controls

Product Code MML Weights, Eyelid, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5700
Definition Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure)
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Audrey Vitale, LLC
Stuart March

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MML Weights, Eyelid, External

All 7
Devices cleared under the same product code (MML) and FDA review panel - the closest regulatory comparables to K170591.
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
K150986 · Meddev Corporation · Aug 2015
LID CHAIN EYELID WEIGHTS
K021750 · Jedmed Instrument Co. · Jan 2003
SUTUREGROOVE
K994289 · Iop, Inc. · Apr 2000
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
K990224 · Labtician Ophthalmics, Inc. · Apr 1999
LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS
K983607 · Labtician Ophthalmics, Inc. · Jan 1999
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
K971242 · Ipax, Inc. · Dec 1997