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Companies / Elixir MD
Medical device company profile

Elixir MD

LED photobiomodulation and facial imaging technology for plastic surgery practices.

Medical Device ManufacturerDermatology & AestheticsMedical AestheticsPlastic SurgeryCommercial LED therapy device; emerging facial imaging offering
Headquarters🇺🇸Irvine, California, United States
Founded2023
Commercial statusCommercially availableLED device offered to plastic surgery practices; named practice use and ANZ channel documented. EVA 3D app is available with manufacturer-reported clinical pilots.
Employees51–200 [1]LinkedIn company-size range · Checked 2026-10-17
Estimated revenueNot confirmed
Official websitewww.elixir-md.com ↗

Company overview

Elixir MD is a privately held medical technology company based in Irvine, California, United States. Its company profile reports a 2023 founding. The business focuses on photobiomodulation for plastic surgery practices and also promotes EVA 3D facial imaging for consultations and surgical planning.

Its ELIXIR MD LED device uses four light bands and is marketed through branded perioperative and skin maintenance protocols. FDA cleared the device in July 2024 for specified dermatological and temporary pain-relief uses. That decision does not establish the broader advertised claims about faster surgical healing or reduced complications. EVA 3D is a separate offering with manufacturer-reported pilot use; its U.S. authorization status was not established.

Athré Facial Plastics in Houston publicly documents using Elixir MD before surgery and during recovery, providing a named example of practice adoption. The manufacturer also announced an Australia/New Zealand subsidiary and an exclusive partnership with High Tech Medical in August 2025. These sources document use and a sales channel rather than comparative clinical outcomes or market share.

[1][5][8][10][12][13]

Leadership

1 people
Ewan YassenFounder and Chief Executive Officer [8]

Products & regulatory status How does MedTechIndex get this information?

Summary

The ELIXIR MD LED platform has FDA clearance K241293 under Yassen Wellness. Its labeled dermatologic uses must be distinguished from broader postoperative-healing marketing. EVA 3D is a separate visualization offering and does not inherit the LED device’s clearance. [7][3][8][9][14]

No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [16][17]

Regulatory snapshot How to read this snapshot

U.S. FDA
1
510(k) clearances
0
De Novo grants
0
PMA approvals
0
Recall events

Latest recorded source review: 2026-10-20.

Scope: selected product families.

Commercial portfolio snapshot

Documented commercial product families.

Clinic-based LED photobiomodulation system

ELIXIR MD LED Light Therapy Device ↗

Panel-based light therapy using red, blue, yellow and infrared wavelengths. Branded protocols organize the same platform for perioperative and aesthetic workflows. [9][3][4][5]

FDA-cleared

Offered through manufacturer and clinical practices, including Athré Facial Plastics.

Facial imaging platform and companion app

EVA 3D ↗

Company-promoted 3D facial visualization for consultation and surgical planning, with an iPhone/iPad app published by ELIXIR MD INC. [1][6]

Marketed · regulatory scope varies

Companion app publicly listed; manufacturer reports pilot clinical integrations. Broader hardware availability not established.

Known Distribution Partners

1 partner

Publicly documented relationships; coverage may be incomplete.

PartnerTerritory / scopeProducts
High Tech Medical Pty Ltd [13]Australia and New ZealandELIXIR MD LED photobiomodulation device

Sources checked October 17, 2026.

Activity & Milestones

3 events
2025-08-01 · Commercial

Australia and New Zealand expansion announced

Manufacturer announced an ANZ subsidiary and exclusive High Tech Medical partnership. Local regulatory authorizations were not reviewed. [13]

2024-07-08 · Regulatory

FDA clearance for ELIXIR MD LED device

FDA issued K241293 to Yassen Wellness LLC for specified dermatological and temporary pain-relief indications. [2]

2023 · Corporate

Company founding reported

Company LinkedIn profile lists 2023 as founding year. [1]

19 Cited Sources

Accessed 10/20/2026

[2] FDA K241293 clearance database record ↗U.S. Food and Drug Administration · regulatory database · Published 2024-07-08
[3] K241293 decision, indications and substantial equivalence summary ↗U.S. Food and Drug Administration · regulatory document · Published 2024-07-08
[4] ELIXIR MD INC labeler: LED Light Therapy Device ↗AccessGUDID / U.S. National Library of Medicine · regulatory database
[6] EVA 3D app, published by ELIXIR MD INC ↗ELIXIR MD INC via Apple App Store · product listing
[7] FDA K241293 — LED Light Therapy Device, ELIXIR MD™ ↗U.S. Food and Drug Administration · regulatory record
[8] Founder and CEO statement ↗Elixir MD · company website
[13] Australia/New Zealand subsidiary and High Tech Medical partnership ↗Elixir MD · company announcement · Published 2025-08-01
[14] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record
[15] FDA PMA database — research search ↗FDA / openFDA · regulatory record
[18] FDA UDI database — research search ↗FDA / openFDA · regulatory record
[19] FDA De Novo database — research search ↗FDA / openFDA · regulatory record
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