Medical device company profile

Aerolase

Laser platforms for dermatology and aesthetic procedures, including Nd:YAG and Er:YAG systems.

Medical Device ManufacturerDermatology & AestheticsDermatologyMedical AestheticsCommercial-stage

Headquarters🇺🇸Tarrytown, New York, United States

FoundedNot confirmed

Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.

EmployeesNot confirmed

Estimated revenueNot confirmed

Official websitewww.aerolase.com ↗

Company overview

Aerolase develops medical laser systems for dermatology and aesthetic practices. Its Neo portfolio uses 1064 nm Nd:YAG technology, while the Era portfolio uses an ablative 2940 nm Er:YAG platform, addressing different treatment workflows.

The company’s current portfolio includes Neo Elite and Era Elite branding. A reviewed 2012 FDA decision concerns an earlier named Nd:YAG model family; current model-to-record mapping remains incomplete, so that decision is not presented as blanket clearance for all current products.

Based in Tarrytown, New York, Aerolase combines device development with practitioner education. Historical FDA corrections involving earlier laser models are retained separately from the current portfolio; the two reviewed recall records are terminated.

^[1][10][11]

Leadership

1 people

Pavel EfremkinChief Executive Officer ^[1]

Products & regulatory status How does MedTechIndex get this information?

Summary

Aerolase markets the Neo Elite and Era Elite laser platforms. K120235 is a documented Aerolase decision; older LightPod names and the separately manufactured EXCI308 listing require model-specific interpretation rather than extending one clearance to every current platform. ^{[11][5][10][12]}

The matched FDA history contains 2 distinct recall events: 0 open, 2 terminated. Z-0768-2020 (2019-08-01; terminated): This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device Z-1188-2012 (2011-06-07; terminated): It was discovered that customers were not supplied with a procedure and schedule for calibrating the FriendlyLight YAG lasers. ^[6][7][8]

Regulatory snapshot How to read this snapshot

U.S. FDA

0
510(k) clearances: 0
De Novo grants: 0
PMA approvals: 0
Recall events

Latest recorded source review: 2026-10-20.

Commercial portfolio snapshot

Documented commercial product families.

Medical laser

Neo Elite ↗

1064 nm Nd:YAG laser platform for dermatology and aesthetic applications. ^[11]

Marketed · regulatory scope varies

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Medical laser

Era Elite ↗

2940 nm Er:YAG laser platform for ablative skin procedures. ^[11]

Marketed · regulatory scope varies

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Products with unconfirmed commercial availability

Legacy medical lasers

Earlier Aerolase laser model families ↗

Earlier FriendlyLight and LightPod model families named in FDA records. ^[11][2]

Commercial availability not established

Legacy models; current availability and exact lineage require verification.

Commercial development

Selected current laser platforms described; legacy records do not establish current-model clearance coverage. ^[11]

17 Cited Sources

Accessed 10/20/2026

[1] Current company anniversary leadership reference ↗Aerolase · company website

[2] FDA 510(k) K120235 ↗U.S. Food and Drug Administration · regulatory database

[3] FDA recall Z-1188-2012 ↗U.S. Food and Drug Administration · regulatory database

[4] FDA recall Z-0768-2020 ↗U.S. Food and Drug Administration · regulatory database

[5] FDA K120235 — MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP ↗U.S. Food and Drug Administration · regulatory record

[6] FDA recall Z-0768-2020 — Aerolase Corporation ↗U.S. Food and Drug Administration · regulatory record

[7] FDA recall Z-0769-2020 — Aerolase Corporation ↗U.S. Food and Drug Administration · regulatory record

[8] FDA recall Z-1188-2012 — Aerolase ↗U.S. Food and Drug Administration · regulatory record

[9] FDA K191086 — Exciplex ↗U.S. Food and Drug Administration · regulatory record

[10] Employer hiring source reviewed ↗Aerolase · company website

[11] Laser product portfolio ↗Aerolase · company website

[12] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record

[13] FDA PMA database — research search ↗FDA / openFDA · regulatory record

[14] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[15] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[16] FDA UDI database — research search ↗FDA / openFDA · regulatory record

[17] FDA De Novo database — research search ↗FDA / openFDA · regulatory record