Z-0768-2020Class II

LightPod ERA lasers

Name: Z-0768-2020 LightPod ERA lasers
Creator: Aerolase Corporation
Published: 2019-08-01
License: https://open.fda.gov/license/

Aerolase Corporation / initiated 2019-08-01 / Terminated

FDA source

Aerolase Corporation began a recall of LightPod ERA lasers on 2019-08-01. FDA classified it as Class II and gives the reason as "This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0768-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-01
Posted: 2020-01-03
Terminated: 2021-03-30
Recalling firm: Aerolase Corporation
Product: LightPod ERA lasers
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device
Action: Aerolase notified all customers to whom such product was delivered. Customer will be informed that the firm plan to provide immediately, and without charge, a remote interlock connector for use with their Aerolase lasers. For questions contact Aerolase in Tarrytown, NY at [email protected] or 914-345-8300.
Quantity in commerce: 65
Distribution: US Nationwide Distribution
Product codes and lots: LightPod ERA Lasers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0768-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0768-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-03
Z-0769-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-03

Product code GEX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)