Facility

AEROLASE CORPORATION

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

3inspections · worst OAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004374705
Establishment type	Manufacture Medical Device
Location	120 White Plains Road Tarrytown, NY, US 10591
Registration status	Active · expires 2026
Parent company	AEROLASE CORPORATION (owner-operator 9047647)
Brand names	LightPod Era; Era Elite

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Powered Laser Surgical Instrument
Product code GEX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

Class IITerminated2019-08-01
This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device

FDA inspections (3)

VAI2021-05-20
Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: Devices · citations posted
VAI2019-08-08
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
VAI2017-05-03
Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “AEROLASE CORPORATION (FEI 3004374705) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004374705-aerolase-corporation/

Not open yet

Alerts for AEROLASE CORPORATION

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.